Regulatory Strategy & Dossier Filing

• Regulatory White Paper Preparation
• Pre-submission Meetings
• Scientific Package Preparation
• Regulatory Strategy and Dossier Filing
• Review, Authoring & Dossier Compilation
• Regulatory Compliance & Due Diligence
• Dossier Lifecycle Management
• Regulatory Resources
• Regulatory Artificial Intelligence (Ai)

Regulatory Strategy & Dossier Filing

Regulatory Strategy refers to a structured plan for obtaining and maintaining regulatory approval for a drug product, while Dossier Filing involves the submission of comprehensive documentation to regulatory authorities for market authorization. These processes ensure compliance with global regulatory frameworks such as U.S. FDA (Food and Drug Administration), EMA (European Medicines Agency), MHRA (Medicines and Healthcare products Regulatory Agency), PMDA (Pharmaceuticals and Medical Devices Agency), and WHO (World Health Organization).

A regulatory strategy outlines the roadmap for drug development and approval, considering factors such as clinical trial requirements, Chemistry, Manufacturing, and Controls (CMC) compliance, labeling, safety, and post-marketing commitments. It involves:

• Identifying the most efficient regulatory pathway (e.g., NDA, ANDA, BLA, MAA, IND, DMF).
• Ensuring compliance with ICH guidelines (Q8-Q10 for quality, E6 for clinical trials, M4 for dossier structure).
• Developing a risk-based approach for GMP compliance, pharmacovigilance, and lifecycle management.

Dossier filing refers to the preparation, compilation, and submission of regulatory documentation for drug approval. It follows the Common Technical Document (CTD/eCTD) format, which includes:

• Module 1: Regional information (cover letters, application forms).
• Module 2: Summaries of quality, clinical, and non-clinical data.
• Module 3: CMC data (manufacturing process, analytical methods, stability studies).
• Module 4: Non-clinical study reports (toxicology, pharmacokinetics).
• Module 5: Clinical study reports (efficacy and safety data).

Regulatory authorities review the dossier for completeness, accuracy, and compliance with GMP, GLP, and GCP. Deficiencies may lead to queries, additional data requests, or rejection. A well-defined regulatory strategy and dossier filing process ensure timely approval, market entry, and ongoing compliance for pharmaceutical products.

Masuu provide tailored regulatory strategies specific to each country and health authority, helping pharmaceutical companies efficiently navigate regulatory pathways for drug approval in their intended markets. Our expertise ensures that drug products meet all development and submission requirements from the early phases of regulatory planning through the entire product lifecycle. Whether addressing compliance challenges, optimizing approvals, or managing post-approval changes, we support our clients in achieving a smooth and efficient regulatory process.

We handle all aspects of dossier preparation and submission, ensuring compliance with global regulatory requirements. Our team of Regulatory CMC, Labeling, and Clinical Subject Matter Experts (SMEs) compiles and organizes the required documentation in the appropriate format, including:

• Common Technical Document (CTD/eCTD) – Standard format for global regulatory submissions.
• ASEAN Common Technical Dossier (ACTD) – Required for regulatory filings in Southeast Asian countries.
• Country-Specific Formats – Customized to meet the unique regulatory requirements of different health authorities.

We assist with regulatory submissions for various drug approvals and lifecycle management applications, including:

• ANDA (Abbreviated New Drug Application) – For generic drug approvals.
• NDA (New Drug Application) & 505(b)(2) Applications – For new drugs and hybrid submissions requiring additional clinical data.
• IND (Investigational New Drug Application) – For clinical trial authorization.
• ANDS/NDS (Abbreviated/New Drug Submission) – For Canada-specific approvals.
• MAA (Marketing Authorization Application) – For European drug approvals.
• DMF (Drug Master File), CEP (Certificate of Suitability), and ASMF (Active Substance Master File) – For API and excipient regulatory approvals.
• 510(k) Submission – For medical device approvals in the U.S.

Our expert regulatory team ensures that each dossier is meticulously prepared, accurate, complete, and compliant with global health authority requirements. By eliminating deficiencies and streamlining the submission process, we optimize applications for fast-track approvals and aim for first-cycle acceptance, minimizing regulatory delays.

With our strategic planning and dossier expertise, pharmaceutical companies can confidently submit applications, reduce approval timelines, and bring high-quality products to market faster.