CASE STUDY ON REGULATORY STRATEGY DEVELOPMENT AND DOSSIER SUBMISSION SUPPORT
Geography: N/A
Type Service: N/A
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.