Regulatory & CMC Support
- Preparation, review, and compilation of CMC and technical documentation for APIs and NCEs.
- Support for regulatory queries, deficiency responses, dossiers, protocols, and regulatory submissions.
- Regulatory support for submissions to USFDA, EDQM, ANVISA, DCGI/CDSCO, NMPA (China), PMDA (Japan), and TGA (Australia).
- Support for IND, DMF, ANDA, DCGI/CDSCO, and Clinical Trial Applications.
- Regulatory document writing and technical review, including CMC documentation and supporting reports.
- Preparation and review of API/Drug Substance and Drug Product CMC packages.
- Support for designing of specifications, analytical methods, impurity profiles, stability data, process validation, and manufacturing information.
- Regulatory gap assessment and identification of missing technical/CMC information.
- Preparation of responses to regulatory questions, observations, and deficiencies.
- Co-ordination of technical and regulatory information required for submissions across different markets.
- Support for regulatory strategy and submission readiness for NCE development programs.