Regulatory Affairs | Innoceutica Consulting

Reference Product Identification for bioequivalence studies.
Comparative Dissolution Requirements assessment.
Design and Review of Specifications and Test Procedures, including stability protocols and development documentation, aligned with region-specific guidelines for various dosage forms (tablets, capsules, oral liquids, injectables).
Dossier Due Diligence to ensure completeness and compliance.
Bridging Data Requirements for reliance or review-based evaluations.
Compatibility Data Assessment for excipients and packaging materials.
Labelling Compliance with regional regulatory standards.
Regulatory Liaison – acting as a point of contact with health authorities.
Scientific Advice Meeting Support – planning and leading CMC-related engagements with EMA, FDA, and other agencies.

Dossier Compilation and Submission for EU (MRP, DCP, National), UK (MHRA), Canada (HC), USA (FDA), GCC (Saudi Arabia, UAE), Brazil, and other regions.
Comprehensive Dossier Due Diligence to ensure regulatory readiness.
CMC Section Authoring with technical accuracy and strategic alignment.
Module 1 Preparation tailored to regional requirements.
Marketing Authorization Application (MAA) Management and submission coordination.

Regulatory Change Assessment and Submission Strategy with a pragmatic and compliant approach.
Preparation of CMC and Safety Variations.
Renewal Dossier Compilation.
Grouping and Super-Grouping of Variations, including safety-related updates.
Annual Report Authoring in line with regulatory expectations.

We specialize in drafting strategic responses to regulatory queries, ensuring compliance while maintaining flexibility to meet client business objectives.

Our publishing services include:
- Validated eCTD Sequence Preparation for all regions, ensuring submission-ready formats and compliance with technical standards.