Chemistry, Manufacturing and Controls (CMC) Regulatory Support
Biomapas Regulatory team has the practical experience and essential knowledge in every aspect of Module 3 Quality, offering the preparation of the full document, post-authorization changes assessment, variations preparation and management, and post-authorization strategic support while maintaining quality in all areas of CMC.
- CMC Regulatory Services
- Scientific/technical writing of Quality part for:
- Investigational Medicinal Product Dossier (IMPD);
- New Drug Application (NDA)
- Biologics License Application (BLA);
- Marketing Authorization Application (MAA).
- Investigational New Drug (IND);
- CMC life cycle management activities:
- Change control assessment working with manufacturing sites and variations preparation;
- Post-authorization maintenance and support through effective Life Cycle Management;
- Preparation of responses to Regulatory Agencies questions;
- Dossier amendment and supplement;
- CMC due diligence and gap analysis;
- Preparation, publication, and submission of Electronic Common Technical Document (eCTD).
Biomapas CMC Regulatory Support includes products of all types of APIs (Biologicals, Biosimilars, Chemicals, Herbals, and Homeopathic). Our CMC team ensures smooth and flexible communication with our clients through effective project management and preparation of documents at the highest quality standards meeting the regulatory compliance requirements.
