Regulatory submissions

• 3.4 Regulatory Submissions

3.4.1 Dossier Preparation

• Documents: Compile CTD/eCTD modules (Module 2–3 for quality, nonclinical/clinical data).

• Key Deliverables: Drug Master Files (DMF), CMC (Chemistry, Manufacturing, Controls) sections, and batch records.

• Software: eCTD publishing tools and validation-ready electronic submissions for FDA/EMA/MHRA.

3.4.2 Interactions with Regulatory Agencies

• Services: Pre-IND/NDA meetings, gap analysis, and response to agency queries (IR, CRL).

• Strategic Support: Accelerated approval pathways (Breakthrough Therapy, Fast Track) and orphan drug designations.

• Global Reach: Expertise in FDA (USA), EMA (EU), TGA (Australia), and DCGI (India) submissions.