INNOCEUTICA CONSULTING "Innovating Healthcare....Empowering Strategy"
Regulatory Consulting Services
Tailored regulatory solutions for your unique business needs.
About Innoceutica
At Innoceutica Consulting, our Regulatory Services team is dedicated to guiding drug products through every stage of the global regulatory pathway. We specialize in regulatory strategy development, authoring and managing submissions, coordinating health authority interactions, and ensuring compliance across the product lifecycle.
With expertise spanning CMC regulatory writing, dossier preparation, gap assessments, and readiness for agency reviews and inspections, we deliver strategic, science‑based regulatory solutions. Our mission is to enable a smooth, compliant progression from early development to market authorization—anchored in clarity, precision, and operational excellence.
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.
Regulatory Strategy Consulting
Global Dossier Preparation and Submission
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.
Post-Approval Regulatory Support
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.
Health Authority Query Responses
We specialize in drafting strategic responses to regulatory queries, ensuring compliance while maintaining flexibility to meet client business objectives.
Innoceutica's expertise helped us navigate complex regulatory challenges with ease and confidence.
Pharma Solutions
Their tailored approach significantly improved our submission timelines and ensured compliance with regulations.
Biotech Innovators
