Regulatory Affairs

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Our Regulatory consulting services offered for Pharmaceutical, Biotechnology, API manufactures and medical device companies

Techsol’s Regulatory Center of Excellence (rCOE) strives to keep all our clients updated on the latest updates and changes across different types of GxP and Data Privacy regulations. Our team evaluates business process risks and recommends ideal best practices for adapting and implementing enterprise-wide compliance actions.  With extensive GxP regulatory experience, Techsol has been helping several global companies to strategize and evolve continuously from a compliance perspective right from product development to commercialization.

In recent times, Pharma companies and  Life Sciences organizations are challenged with an increasingly complex regulatory landscape that has evolved dramatically to ensure better public health with a laser focus on patient safety, product efficacy, quality, risk management, transparency, and compliance.

Our Global network of Regulatory Center of Excellence will provide the services for all major markets such as – North America, Europe, Middle East, LATAM, Africa and Asia Pacific. Techsol’s Service Delivery Centers are located in US, South Korea, EU and India.

Techsol Regulatory Compliance

How We Help Clients

To keep up with rapid global, regional, and national policy changes, we help global companies with the following services:

  • Provide insights on regulatory issues global regulatory affairs
  • Strategize and implement best practices for quality, risk, and regulatory related operations
  • Develop a robust Compliance Lifecycle Management framework
  • Consult and implement latest regulatory changes based on its impact on the current processes, market developments, and implementation path
Techsol Regulatory Services

Services We Offer

Our rCOE teams are having extensive GxP regulatory experience and proven track record in successful submissions of various regulatory dossier applications to US, EU, ROW LATAM, GCC, APAC Health authorities. We provide ongoing support to our clients in the interpretation of the regulatory requirements as well as best practices and solutions obtained from our experience with other customers across all our regulatory services.

We have been actively working with several clients to support different clinical trial data electronic submissions using our extensive experience in publishing, assembly and dispatch of eCTD submissions to the FDA, EMA, Health Canada, Swiss Medic and other National agencies worldwide. This includes initial applications like initial MAA, BLA and NDA and life cycle submissions like variations, amendments, commitments, renewals, PSURs and annual submissions.

Publishing documents for regulatory submissions will be done efficiently, according to standardized procedures and workflows, including transparent quality checks. Whether the source document is a Word document, a PDF document or even a paper document, we will ensure that the document becomes eCTD-ready.

  • Review of the dossier before converting to the eCTD
  • eCTD preparation of documentation
  • Documentation maintenance for the duration of the registration dossier
  • eCTD Archiving
  • Preparation of Biometrics eCTD Deliverables
  • Paper dossiers or NeeS to eCTD format and Submissions

We work with global pharma companies to launch their products in the Indian Market after completing product registrations, obtaining import/exports license, and getting manufacturing site registrations.

With our tested regulatory strategies, we can prepare unambiguous dossiers for filing applications for various drug products approval. Our Subject Matters Experts from various therapeutic areas represent our clients at the SEC meetings to obtain approvals and permissions. They also provide Health Authority query responses within the stipulated timelines to obtain approval/permission/licenses without any deviations or compliance risks.

What We Can Do

  • Investigational New Drug (IND) Application
  • New Drug Approval (NDA) Application
  • Subsequent New Drug Approval (SND)
  • Bioequivalence NOC Application for export
  • Represent sponsor in SEC meetings
  • Complete Toxicity Studies
  • Conduct Clinical Trials
  • Obtain Test License
  • Obtain Export and Dual NOC
  • Manufacturing License Application
  • Form 29 for Test Batch
  • Wholesale License
  • Free Sales Certificate

The labelling process is a critical part of pharmaceutical manufacturing and it’s imperative for communicating safety and benefit-risk information to patients and healthcare professionals and Health authorities on regular basis.

Labeling and artwork management is highly regulated process in pharmaceutical industry, Recently, so many drug recalls attributed to errors in product labeling and packaging artwork.  Product Labelling errors could pose a significant risk to patient safety, resulting in an occurrence of regulatory non-compliance. This in turn leads to product recalls, heavy fines, warning letters, and ultimately its damage the brand reputation.

End-to-End Product labeling is a critical process to bring a product from development to market on time, as it encompasses multiple stakeholder groups, from Pharmacovigilance and Regulatory to Artwork and Manufacturing; and spans from signal to patient across markets and geographies.

Our Expertise

Global Labelling Management

We help our clients in creation and updating of Product specific Company Core Data Sheet (CCDS) for Global Labelling Management process. CCDS is a centralized safety information document which contains the up-to-date product safety information which receives from Pharmacovigilance team. We offer following services:

  • Prepare, maintain and distribute Company Core Data Sheet (CCDS)
  • CCDS can be updated with post-marketing safety data, Health Authority updates, Pharmacovigilance Risk Assessment Committee (PRAC) recommendations, literature references, etc.
  • Creation of executive summary documents to track all changes relevant to CCDS revisions
  • Create and maintain Reference Safety Information (RSI)
  • Providing inputs to reference the safety information section in PBRER.
  • Preparation and QC of label documents such as:
    • Clinical Overview (CO),
    • Non-Clinical Overview (NCO),
    • Justification Documentation (JD), etc
  • Support for Global Labeling Change Request Management (Tracking, HA Submission and Implementation).

Local Labelling Management

Local labeling process is very complex process. For each country, there are local regulations which need to be adhered to, and the consequence is that companies need to manage multiple label templates for many countries, leading to a higher chance of mislabeled and therefore recalled products. Poduct Labeling requirements must comply with the country specific regulatory labeling requirements, failing to meet these requirements will have led to Labelling errors could pose a significant risk to patient safety, resulting to product recalls, heavy fines, warning letters, and ultimately damage the brand reputation. Techsol provides local labeling services which include:

  • Prepare and maintain
    • Country specific labels and prescribing information
    • Patient Information Leaflets / Medication Guides / Promotional Material
    • Structured Product Labeling (SPL) and Physician Labeling Rule (PLR)
    • Basic Patient Leaflet (BPL)
    • Medication Guides and Instructions for Use
  • Support Health Authorities (HA) on
    • Interactions and negotiations
    • Labeling queries
  • Collaborate cross-functionally with therapeutic groups for label development & review
  • Implementing the CCDS updates into the country specific labels
  • Comparative analysis of local label content
  • Proofreading and Quality Control (QC)
  • Local label safety alignment with reference label
  • Comparison of Labels for HA submissions

Medical Device Labelling

Medical device product labelling regulations are evolving constantly to provide more transparent information on patient safety, risks, warnings, symbols and precautions.label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.

As results of new MDR and IVDR regulations, each Manufacturer shall maintain and publish the eIFU on company websites and in applicable regional languages. The medical device labeling includes any type of packaging or device identification, as well as anything that describes the device, its capabilities, and its intended use.

Techsol offers end-to-end medical device labeling services that span across updating, reviewing, analyzing, tracking, and maintaining medical device labeling changes.

  • Label compliance
  • Life cycle management (post approval services/changes)
  • Local regulatory requirements alignment
  • Create, update & review contraindications, warnings, precautions
  • Create, update & review Instructions for Use (IFUs), patient information / patient guides, treatment guides, user manuals, maintenance manuals and other types of labeling components
  • Quality check of submission and commercial artworks
  • Gap analysis between distributed labels & submitted labels
  • Tracking global medical device and EU MDR labeling requirements and changes
  • Investigational Device Labeling Requirements
  • Unique Device Identification
  • Symbols in Labeling
  • Symbology management

Artwork Management

Artwork management is required to market your products for compliance with local regulations. TechSol provides Labeling and Artwork services for Pharmaceutical and Medical Devices delivering cost effective and compliant artwork solutions.

  • Creative Artwork Design from Development to Life Cycle Management of labeling
    • Creation of die line / templates for labeling creation
    • Creation and maintenance of Graphic Design labeling components (labels, cartons, blister packs, pouches, package inserts, etc)
    • Multi-language labeling creation
    • Effective Proof reading / QC check process
  • Support labeling change requests for:
    • All types of launches as per launch strategy
    • Labeling text modifications
    • Submission mock-ups
    • Product line extensions
    • Manufacturing / Packaging Site changes
    • Regulatory / legal changes
    • Serialization
  • Coordination with different stakeholders for artwork creation and approvals
  • Color standard review and approval
  • Liaise with printer for final printing of packaging materials

With increasing regulatory complexity across global markets, company expansions with mergers and acquisitions, Chemistry, Manufacturing, and Controls (CMC) organizations are overwhelmed with complex operational challenges. With our highly capable team members, we can help in optimizing your organization’s operations, and fulfill various medical writing needs.

CMC Services

  • CMC regulatory strategy, critical review and assessment, related to the content of the DS (Synthetic or semi-synthetic small molecule, natural product, peptide) and DP (tablet, capsule, patch, cream, wafer, solution, injectable) Quality Modules (Module 2: QOS and Module 3: Quality) of the Common Technical Document (CTD) for regulatory submission
  • CMC content authoring for IND, CTA, IMPD, DMF, NDA, ANDA, MAA
  • CMC Regulatory Gap Analysis for Identification, Assessment and Provision of CMC Regulatory Mitigation Strategies for Remediation
  • Authoring of Annual Report, Drug Master Files, Dossier Amendments and Supplements
  • Preparation, Publishing and submission of Electronic Common Technical Document (eCTD) applications
CMC Medical Writing

News & Updates

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Global Regulatory Changes in Biopharma

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ICH’s eCTD Version 4.0 – Objectives, Major Updates, Resulting Advantages and Possible Challenges

ICH’s eCTD Version 4.0 The Electronic Common Technical Document (eCTD) has become the global standard for electronic submissions in the Life Sciences industry. An eCTD submission has five modules: Region-specific information Summary documents Quality-related information Nonclinical study reports, and Clinical study reports. Most global regulatory agencies such as US FDA (USA), EMA (EU), Health Canada [...]

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