Validation & Assurance Archives - Techsol Life Sciences

CASE STUDY ON REGULATORY STRATEGY DEVELOPMENT AND DOSSIER SUBMISSION SUPPORT

Vinoth — Tue, 10 Jun 2025 06:26:34 +0000

CASE STUDY ON REGULATORY STRATEGY DEVELOPMENT AND DOSSIER SUBMISSION SUPPORT

 Geography: Global 

 Type Service: IND,NDA,ANDA,BLA,CTA,MAA and other Regulatory Submissions

Background/Client Requirement:

Techsol Life Sciences was approached by clients for developing pharmaceutical and medical device products requiring clinical trial approvals and market access across multiple regulatory markets including the USA, India, Europe and other regions.

Project Objectives:

Develop and implement regulatory strategies aligned to clinical trial and device submission requirements.
Compile and review regulatory dossiers in accordance with country-specific requirements (e.g., CDSCO, FDA, EMA, PMDA etc).
Ensure submission packages were complete, accurate, and aligned with applicable standards (ICH, GCP, ISO 14155 etc).
Facilitate smooth and timely communication with health authorities.
Support query responses, amendments, and lifecycle submissions.

Techsol Approach:

Strategic Planning:

Collaborated with client regulatory teams to understand product profiles, submission timelines, and target markets.
Identified applicable regulatory frameworks including 21 CFR Part 312 (USA), NDCT Rules 2019 (India), MDR 2017, EU MDR, EU IVDR & country-specific mandates.
Developed customized regulatory roadmaps for Clinical Trial Applications, Import License, Medical Device Clinical Investigations and Product Registrations.

Gap Analysis and Documentation Review:

Conducted comprehensive gap assessments against authority requirements.
Identified missing technical, clinical, and quality data.
Created region-specific checklists covering required forms, labeling formats, and declarations.
Performed internal quality review and ensure documents meet regional formatting and technical standards.

Dossier Preparation and Compilation:

Techsol regulatory team prepared complete and compliant submission packages aligned with the specific requirements of global health authorities such as the US FDA, EMA, CDSCO.

For medical devices, we ensured that all technical documentation was compiled as per relevant regulatory authorities such as MDR 2017, EU MDR Annex II and III, including device descriptions, design and manufacturing information, risk management files, clinical evaluation reports, and post-market surveillance documentation.
For biopharma products, we prepared CTD-format dossiers compliant with ICH M4 guidelines, covering modules on quality, non-clinical, and clinical data. Used validated publishing tools and adherence to regional guidance (e.g., Module 1 requirements) support seamless compilation and submission.

Submission Management:

We facilitated electronic submissions via regional portals such as the US FDA ESG gateway, EMA’s Common European Submission Portal (CESP), India’s SUGAM and NSWS systems, and the EU Clinical Trials Information System (CTIS).
We have successfully submitted all regulatory dossiers within the stipulated timelines and effectively managed responses to deficiency letters, FDA Information Requests (IRs), Notified Body questions during EU conformity assessments, and CDSCO queries related to clinical trial applications, product imports, and medical device clinical investigations.
Handled eCTD publishing, XML backbone creation, and document granularity.

Process Flow

Challenges:

Tight Timelines: Submission schedules were often highly constrained, and any delay in regulatory approvals had the potential to significantly impact the client’s overall project milestones.
Complex and Region-Specific Regulatory Requirements: Regulatory frameworks for application submissions vary widely across different countries and regions
Interpretation and Alignment with Client Needs: Interpreting regulatory expectations accurately and translating them into actionable guidance that aligned with both regulatory standards and the client’s objectives was a complex task, often requiring a careful balance between compliance and strategic flexibility.

Solutions:

The use of detailed submission roadmaps, standardized templates, and concurrent task execution allowed the Techsol team to speed up the preparation and validation of documents. Frequent internal checkpoints made sure that all tasks stayed on schedule and aligned with essential deadlines.
A robust internal regulatory intelligence system was maintained. Dedicated regional regulatory experts ensured up-to-date country-specific compliance, reducing risks and expediting approvals.
Regular status meetings and joint discussions enabled Techsol to customize regulatory strategies that satisfied both regulatory requirements and the specific objectives of the clients. This approach struck a balance, ensuring compliance while supporting the client’s development strategy.

Project Achievements:

Successfully submitted over 50 clinical trial and medical device dossiers without rejections.
Secured first-round approvals from regulatory agencies such as FDA, EMA, and CDSCO.
Enabled clients to initiate clinical trials and launch products on schedule.
Effectively addressed regulatory challenges, reducing approval delays.
Received direct client appreciation for timely, high-quality submissions.

The Outcome:

Techsol’s regulatory support enabled clients to meet critical development milestones, secure agency approvals, and enter new markets with confidence. By combining scientific expertise, process efficiency, and compliance excellence, Techsol reinforced its position as a trusted regulatory partner across biopharma and medical device industries.

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The post CASE STUDY ON REGULATORY STRATEGY DEVELOPMENT AND DOSSIER SUBMISSION SUPPORT appeared first on Techsol Life Sciences.

CASE STUDY ON MEDICAL DEVICE PRODUCT REGISTRATION IN INDIA

Vinoth — Tue, 10 Jun 2025 05:46:05 +0000

CASE STUDY ON MEDICAL DEVICE PRODUCT REGISTRATION IN INDIA

 Geography: Global

 Type Service: Regulatory

Client Background/Client Requirements:

The client is a leading global medical device manufacturer headquartered in Germany, specialized in developing technologies for diagnostic technologies for diabetes management. The company is a leader in healthcare industry and also produces sterile and non-sterile lancing devices and lancets used for capillary blood sampling in blood glucose monitoring.

The client contacted Techsol Life Sciences to assist them in the Product registration of their medical devices for import and distribution to increase their Sales and Distribution in India. Throughout the CDSCO Import Registration process, Techsol Life Sciences assisted the client by ensuring that all regulatory guidelines were fulfilled on time

Project Objectives:

The objective of the project was to obtain regulatory approval for a Class B medical device categorized as a lancing device and lancets used for capillary blood sampling. These devices are intended for both professional use in Diagnostics and home-based diabetes self-monitoring by individuals. The key indications include blood glucose monitoring in patients with diabetes.

The regulatory goal was to obtain a Product Registration / Import License from the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules (MDR), 2017, by submitting a complete dossier through the SUGAM portal.

Regulatory goals :

To ensure full adherence to Medical Device regulatory standards, which includes MDR 2017, labeling, risk assessment, and robust Post-Market Surveillance (PMS) strategy.
To prepare a quality, submission-ready import license/ Product Registration dossier before submission to minimize the possibility of CDSCO queries.
To obtain the approval of Import License / Product Registration within the stipulated timelines of the original application being submitted to Regulatory Authority

Techsol Approach :

Our client’s medical devices were intended to be imported and distributed commercially in India from Germany. Techsol established a systematic approach for regulatory Strategy that was tailored to the project’s commercial timelines and CDSCO guidelines.

Phase 1: Project Initiation and Planning

Kick-off Meeting: Upon contract signoff Techsol Project Manager will conduct a detailed kick-off meeting with the sponsor to align on scope, timelines, expectations, and responsibilities
Regulatory Strategy: Techsol Regulatory team will review the medical device details confirming its risk classification as per Indian MDR 2017 rules and develop the regulatory strategy for the Import License/ Product registration approval process in India.
Gap Assessment: Techsol Regulatory Team will provide the gap analysis checklist to the Sponsor, upon receiving documents from the sponsor, Techsol Regulatory team will review the source documents and confirm the classification of the device as per the Indian MDR 2017. If any deficiencies/gaps are identified same will be communicated to the sponsor

Phase 2: Dossier Compilation and Submission

Upon receiving the supporting documents as per MD-14 checklist Techsol Regulatory Team will prepare the dossier for compilation and submission to CDSCO. The regulatory dossier includes the following major components:

Covering Letter
Power of Attorney (POA)
Copy of Whole Sale license / Manufacturing license
Free Sale Certificate (FSC)
Overseas Manufacturing Site Registration Certificate
Quality Certificates (ISO 13485)
CE Certificates (Product/Design/Type)
Declaration of Conformity
Site Master File (SMF) / Plant Master File (PMF)
Device Master File (DMF)
Instruction for use (IFU)

The final submission was made via the SUGAM portal, with all applicable fees paid under Schedule II of MDR 2017

Challenges:

Post submission of the dossier following issues/ challenges are identified.

Authentication of Regulatory Documents: Notarized, apostilled, or embassy-authenticated copies of documents (e.g., Power of Attorney, Free Sale Certificate, CE Certificate, Quality Certificate, and Manufacturing Site Certificate) were required but initially submitted without proper attestation, leading to delay in regulatory approval.

Submission of Specimen Batch Test Reports: During the initial submission, only generic batch data was provided, which is inadequate. CDSCO requires test reports for at least three consecutive batches covering all relevant parameters.
Labeling Compliance with MDR 2017: Product labels were not in line with MDR 2017 requirements. Key information such as the importer/distributor name, manufacturer details, and expiry/manufacturing date were missing.
Shelf-life Justification: Proper shelf-life justification is critical for maintaining product sterility, safety, and performance. Inadequate data or rationale may lead to regulatory concerns about device efficacy and patient safety.
Digitally Signed Import License Application: The legal form (Form MD-14) must be digitally signed for submission via the SUGAM portal.

Project solutions:

Techsol played a crucial role in securing regulatory approval license for our client by streamlining the medical device registration process. By Employing a series of strategic actions focused on adherence to regulations, precise documentation, and responsive support. Techsol was able to facilitate a seamless registration process that not only minimized delays and risks but also exceeded client expectations.

Techsol assisted the client in ensuring all critical documents i.e. Power of Attorney (PoA), Free Sale Certificate (FSC), CE Certificate, and Quality Management Certificates must be apostilled and notarized, preventing further delays and ensuring compliance with Indian MDR 2017.
Techsol advised the client to perform standardized testing across three consecutive manufacturing batches of the lancets and glucometer strips. All test reports were verified by the manufacturer’s QA head as per the MDR 2017 requirements and submitted as part of the revised 3 consecutive manufacturing batches.
Techsol Regulatory labelling experts performed the detailed label reviews and offer labeling remediation services to ensure full compliance with MDR 2017. Techsol also assist in the design and validation of compliant artwork and labeling requirements.
Techsol informed the client’s global regulatory and R&D teams to collect real-time and accelerated stability data. A scientific justification letter was prepared outlining the rationale for the proposed shelf-life, referencing ISO 11607 (for sterile barrier systems) and ISO 10993 (for biocompatibility).
Techsol ensured that the legal application form (Form MD-14) was digitally signed using a valid Digital Signature Certificate (DSC).

Project Achievements:

Error-Free Documentation – Techsol ensured the submission included accurate and complete documentation, such as the MD-14 and MD-16 forms, meeting CDSCO’s stringent standards.
On-Time Submission – Despite tight deadlines, Techsol managed to submit the application on time, meeting the client’s strategic timeline for market entry.
Regulatory Approval and Compliance – The client received approval for their medical device registration within the anticipated timeframe, enabled by Techsol’s systematic and efficient approach.

Project Outcomes:

The product registration / import license application approval MD-15 has received within the stipulated timelines
Two rounds of CDSCO queries were effectively addressed, focusing on labeling compliance, additional data, shelf-life justification, and document formatting.
Techsol Regulatory team has provided responses and maintained the proactive communication with the Regulatory authority.

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CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL)MANAGEMENT SERVICES

Vinoth — Mon, 09 Jun 2025 08:03:13 +0000

CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL) MANAGEMENT SERVICES

 Geography: N/A
 Type Service: N/A

Background/Client Requirement:

Our client, a U.S. based leading pharmaceutical company, established with a focus on providing affordable, high-quality medications, specializes in the development, manufacturing, and distribution of generic pharmaceuticals for the U.S. market. With a commitment to improving healthcare accessibility, the company focuses on therapeutic areas such as respiratory diseases, HIV/AIDS, Oncology, Cardiovascular, Diabetes, and many others infectious diseases.

They approached Techsol Life Sciences to manage the full lifecycle of Structured Product Labeling (SPL) for its product line, covering new product entries (SPL Creation), SPL Updation (safety updates), and Delisting (product discontinuation).

Project Objectives:

To provide end-to-end management of Structured Product Labeling (SPL) focusing on SPL Creation, Update, and Delisting, ensuring full regulatory compliance with U.S. FDA labelling requirements and HL7 standards.

SPL Creation: To Create a structured product labeling (SPL) in XML format for newly approved drug, ensuring it meets the FDA’s labeling and submission standards.
SPL Update: To update the existing drug SPL with latest safety information and labels to comply with FDA standards.
SPL Delisting: To ensure the efficient removal of a drug listing from the FDA’s Structured Product Labeling (SPL) database.

To deliver a seamless, timely and error-free SPL for the client while minimizing regulatory risk and ensuring that the product’s listing is reflected in FDA database systems.

Techsol Approach:

Project Initiation: Upon contract signoff Techsol Project Manager will provide the brief overview about the project scope, timelines, expectations, and responsibilities.

Gap Analysis: Techsol Regulatory team will perform a detailed gap analysis to identify missing/ required information in the following categories:

Header Elements: Drug name and details, Version details, Labeller information, Registrant details, Establishment and business operations.
Data Elements: Drug names, dosage form, Application details, Marketing date, Characteristics, and Packaging Information.
Contents of Labeling: Information for all required sections, Revised date, IFU (if applicable) and Labels.

XML Based SPL Authoring:

SPL Creation: The SPL creation process begins with extracting relevant information from the client’s source Prescribing Information Leaflet (PIL). This data is carefully incorporated into designated sections of the SPL, including Header information, Data Elements, and contents of labeling. Depending on the dosage form, additional sections such as Labels, Instructions for Use (IFU), and Medication Guides are completed with appropriate content.
SPL Update: Updating the SPL content in XML format, including Document IDs, Section IDs, Version Number, Revised date, New labels with existing labels and other content of labeling sections with outdated or new information mainly Warnings and Precautions, Adverse Reactions, Drug Interactions, and Patient Counselling Information.
SPL Delisting: The product’s marketing status was updated from “ACTIVE” to “COMPLETED.” This update is essential to signify the product’s end-of-life phase, with the marketing end date documented as required by the FDA, typically using the expiration date of the last produced lot.

Validation and Error resolution: Once all necessary data is integrated, the SPL is validated to verify XML compliance. Any XML or structural errors identified during validation are corrected using SPL validation guide to ensure full compliance with labelling requirements.

Final QC: Designated personnel will perform the QC review to ensure all content meets FDA requirements, is free of validation errors, and accurately reflects updated safety information.

QC Process Flow

Approval: Upon completion of internal QC, the final SPL will be shared with the Sponsor for their review and submission.

SPL Management Process Flow:

Challenges:

Complexity: The standards for SPL are highly complex, demanding precise adherence to specific formatting, terminology, and metadata guidelines. The Validator may face challenges in accurately interpreting and validating SPL data.
Addition of Images: A significant challenge was managing reference value errors in file, particularly during the integration of images, which needed to comply with specific formatting requirements and section placements within the product.
Formatting Tables: Another notable challenge was formatting tables, particularly addressing errors such as ‘Attribute ‘width’ is not allowed to appear in element ‘td’ and ‘Attribute ‘align’ is not allowed to appear in element ‘paragraph.’. Additionally, many tables in the product update contained images within the table cells, further complicating the process.
Section ID Discrepancy: Submission errors due to Section ID either not aligning with IDs in other documents or repeating from previously submitted section IDs.
Missing or Incorrect Revised Date Entry: The Revised Date in the SPL must accurately match the date provided in the PIL; however, this poses a challenge when the required date is in the past, as the tool automatically captures the current date and time during editing.
Timeliness: Submissions are often required within 24 hours, leaving limited time for SPL XML preparation, validation, and formatting especially when dealing with complex technical content.

Solutions:

Complex SPL Standards: Techsol team conducted thorough review of FDA SPL guidelines to ensure accurate formatting, terminology, and metadata compliance. Using tools like the Pragmatic Validator, the team quickly identified and resolved formatting and validation issues.
Addition of Images: Our team optimizes image formatting and placement to meet SPL structural requirements, preventing reference value errors and ensuring smooth validation.
Formatting Tables: Techsol reformats tables using SPL guides to remove disallowed attributes, ensuring error-free submission.
Section ID Discrepancy: We implement a robust cross-referencing system and maintain and ensure IDs are unique and consistent across all submission files.
Missing or Incorrect Revised Date Entry: The team manually adjusts and validates the revised date in alignment with PIL, overriding auto-generated date to ensure regulatory consistency.
Timeliness: With a dedicated SPL team and pre-configured workflows, Techsol delivers compliant SPLs within 24 hours, even under urgent timelines.

Project Achievements:

The Techsol team has consistently delivered over 100+ Structured Product Labeling (SPL) submissions to date, ensuring all were error-free, submitted within agreed timelines, and fully aligned with regulatory labeling standards and client-specific requirements.

End-to-End SPL Lifecycle Management:

Techsol successfully managed the full Structured Product Labeling (SPL) activities, including creation for new products, safety-related SPL updates, and regulatory delisting of discontinued products.
Created high-quality, XML-based SPLs for newly approved drugs using accurate metadata, structured content sections, and FDA-compliant terminology.
Updated key sections including Warnings and Precautions, Adverse Reactions, Drug Interactions, and Patient Counselling, ensuring alignment with current FDA safety requirements. Integrated complex tables, revised labels, and embedded images without validation errors.
Updated product marketing status leading to successful delisting of obsolete products from FDA systems. Maintained data integrity and ensured seamless delisting from DailyMed with no XML Errors.

Error-Free Submissions:

Addressed complex XML formatting issues including attribute errors, section ID mismatches, and revised date discrepancies.
Used FDA validation tools and manual checks to eliminate all structural and content-related validation issues.
Achieved a 100% success rate in FDA SPL validation with zero rejections or resubmissions.

Streamlined Processes:

Developed a standardized internal SPL QC checklist and validation process that ensured consistency and reduced turnaround time.
Maintained continuous communication with the client’s regulatory team for data collection, content approval, and expedited review cycles.

Timely Submission:

Established SPL authoring team capable of completing high-quality SPLs within 01 business day during priority submissions.
Demonstrated flexibility and reliability in delivering under stringent regulatory deadlines without compromising quality and compliance.

Client Appreciation and Feedback: We would like to express our appreciation to the Techsol team for the timely delivery of high-quality regulatory SPL Your consistent adherence to timelines and exceptional attention to detail have significantly contributed to the efficiency and success of our submission process.

The Outcome:

XML file creation: SPL XML files were created, updated and delisted as per client’s requirement.
Regulatory Compliance: All SPL submissions complied fully with FDA and HL7 standards, with no validation errors or format-related rejections.
Zero Errors: Submitted SPLs were thoroughly reviewed and passed all technical validations, ensuring FDA acceptance.
On-Time Delivery: Completed SPL creation, update, and delisting within the client’s defined timelines, supporting their regulatory strategy and market commitments.
Published on DailyMed: The final SPL XML file is submitted to USFDA and published on DailyMed.

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Case Study on Clinical Evaluation of Prosthodontic products

Vinoth — Tue, 27 May 2025 06:13:10 +0000

Case Study on Clinical Evaluation of Prosthodontic products

Geography: Global
Type of service: Regulatory Writing

Background/Client Requirement:

A prominent international producer of Prosthodontic devices, renowned for its groundbreaking advancements in Dental health/hygiene, outsourced Techsol Lifesciences to craft clinical evaluation Report (CER) for their dental products and surgical devices, ensuring compliance with the EU MDR 2017/745 and TGA standards.

Project Objective:

The aim was to develop and uphold essential components of the CE technical documentation for regulatory submissions of medical devices in the EU and TGA, including the Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), and Literature Search Reports (LSR).
Techsol Approach:

This involved conducting a thorough systematic literature review on the medical device and State-of-the-Art, assessing both non-clinical and clinical data provided by the manufacturer and to incorporate real-world evidence from adverse event databases. Furthermore, conducting a robust analysis of the devices’ safety, performance, and benefit-risk profile to ensure compliance along with General Safety and Performance Requirements outlined in the EU MDR.
Techsol provided support to the company for various activities related to their Class I, IIa, and IIb devices, including:

Authoring CEPs, CERs, and LSRs to ensure compliance with EU MDR 2017/745.
Evaluating the sufficiency of clinical data by analyzing product history, pre-clinical and clinical studies, complaints, adverse events, and literature.
Swift processing and analysis of large volumes of data, facilitating rapid literature review.

Challenges:

Managing a high volume of literature hits and post-market data presented several challenges:

Data Overload: Sorting through a large number of literature hits and post-market data was overwhelming, leading to information overload and difficulty in identifying relevant insights in short time.
Data Quality: Ensuring the quality and reliability of the literature and post-market data was crucial. With a high volume of data, there was an increased risk of encountering low-quality or irrelevant information, which could have impacted decision-making.
Timeliness: Processing a large amount of data within tight timelines was challenging. Delayed analysis could have impeded timely decision-making or regulatory compliance.

Solutions:

Techsol collaborated closely with the client to craft a comprehensive literature search strategy, pinpoint analogous devices, and scrutinize the amassed clinical data derived from the device’s market utilization.
Created search strings for extensive search of available literature
The Techsol team authored the Clinical Evaluation Plan and Report, encompassing the Literature Search Report, in alignment with EU/MDR 2017/745 and MEDDEV 2.7/1 Rev.04 standards. Modifications were made to the literature search strategy for the Clinical Evaluation Report to harness data pertaining directly to the treatment modality, ensuring the development of a comprehensive State of the Art discussion.
Evaluated the sufficiency of clinical data by examining product history, pre-clinical and clinical studies, reports of complaints and adverse events, as well as evidence collected from literature reviews and state-of-the-art analyses.

Project Achievements:

Techsol continues to deliver regulatory documentation via an end-to-end process involving the right stakeholders to achieve:

Comprehensive Documentation: Our team successfully authored CERs, ensuring comprehensive documentation of the clinical evaluation process for each medical device. This included detailing the methodology, data sources, analysis, and conclusions drawn.
Regulatory Compliance: The CERs were crafted meticulously to meet the stringent regulatory requirements of EU MDR 2017/745. By adhering to regulatory guidelines, the company demonstrated its commitment to ensuring the safety and efficacy of its medical devices. > 98% quality & timeline delivery performance despite tight timelines, an achievement in collaborating with Techsol’s expertise

Improved compliance based on guidance from Techsol’s regulatory experts
Evidence-Based Approach: Our team utilized an evidence-based approach, incorporating a systematic literature review, literature review, evaluation of clinical and non-clinical data, and real-world evidence from adverse event databases. This rigorous methodology strengthened the credibility and reliability of the CERs.

Project Outcome:

Techsol’s constant support in clinical evaluation documentation, coupled with industry best practices, has been instrumental in the partnership’s success. This achievement is attributed to the collaboration between experienced resources and the client’s regulatory team. Through leveraging Techsol’s expertise, multiple documents are delivered swiftly, meeting expedited timelines without compromising quality. This streamlined approach ensures compliance with regulatory standards while maximizing efficiency.

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Implementation and Validation of a Cloud-based Clinical Data Management System for a Leading Pharmaceutical Company

Vinoth — Wed, 24 Jan 2024 11:23:14 +0000

About Client:

Our client, a top 5 Indian pharmaceutical company headquartered in Hyderabad, India, specializes in the development, manufacturing, and distribution of various generic formulations, active pharmaceutical ingredients (APIs), biosimilars and proprietary products. The company’s generic products are indicated for the treatment of gastrointestinal disorders, various cancer types, pain, cardiovascular diseases, central nervous system disorders, infectious diseases, and pediatric diseases.

Operating in over 100 countries, they are committed to improving global healthcare access, promoting innovation, and enhancing patient well-being.

how can we help you?

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Conclusion:

Techsol’s validation expertise and collaborative team effort resulted in the successful implementation of Oracle’s Clinical One application for the client empowering them to establish their in-house clinical data management operations. The collaborative development of new SOPs and work instructions for using the Clinical One application was a key learning for Techsol as it involved multiple discussions with various stakeholders from the client side. With this success, the client has now entrusted us to provide application support after Go-Live to ensure business continuity.

Client Testimonial

“Our decision to bring in-sourcing was driven by the desire for greater control, efficiency, and the ability to tailor our processes to meet the specific needs of our clinical trial programs. This milestone is the culmination of months of meticulous planning, hard work, and collaboration across teams. We would like to give a special shout out to Techsol team members for their exceptional contributions, hard work, and support in timely completing the Clinical One systems validation and CDM process development.

The successful go-live of Clinical one sets a high standard for the continued phases of this initiative and have full confidence that our dedication and collaborative spirit will carry us forward to accomplish our business goals around clinical data management.”

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Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals

Vinoth — Thu, 29 Dec 2022 10:25:02 +0000

Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and conﬁguration.

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Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma

Vinoth — Thu, 29 Dec 2022 09:49:42 +0000

Hugel Pharma, a global biotechnology firm, had a few approved products that were ready for marketing. The organization, however,did not have a safety system in place. They were looking for a partnerthat could deliver a safety system in a timely manner.

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Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution

Vinoth — Thu, 29 Dec 2022 09:07:51 +0000

Ipca is an established Indian pharmaceutical company manufacturing over 350 formulations and 80 active pharmaceutical ingredients for various therapeutic segments. Headquartered in Mumbai, Ipca manufactures and sells branded and generic formulations, APIs and intermediates to 120+ countries. As one of the world’s largest drug manufacturers, they are inspected by US-FDA, UK-MHRA, EDQM- Europe, WHO-Geneva, PMDA and many other regional regulatory bodies.

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Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax

Vinoth — Tue, 27 Dec 2022 07:39:11 +0000

Based out of South Korea, GemVax is one of the leading pharma research and development organization conductiong R & D for anti-cancer iimunotherapeutic and peptide drugs.

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