Chemistry, Manufacturing, and Controls (CMC) Management Services
Full life cycle support from early-stage development to post approval and beyond
At Navitas Life Sciences, our global team of practised and highly qualified CMC professionals provides comprehensive support across the full product life cycle. From early-stage development to post approval and beyond, we help you meet all your CMC needs with precision and expertise.
Our CMC Regulatory services include:
CMC Technical Authoring
- Content authoring via pharmaREADY®DMS using CTD templates of modules 2.3 and 3 (Drug Substance and Drug Product) for IND, NDA, ANDA, Initial MAA, baseline submissions, annual reports, drug master files, amendments, and supplements
- Review of R&D and manufacturing documents for CMC technical authoring
CMC Change Control Management
- Managing dossier compliance and change control assessment via rimREADY®
- Coordinating and delivering CMC content for dossier preparation to Boards of Health (BoH)
- Preparation, publication, and submission of electronic Common Technical Document (eCTD) applications
- Life cycle Management via pharmaREADY® DMS and eCTD
CMC Dossier Compliance
- Dossier review, data consistency, gap analysis and remediation, and due diligence assessment
- Responses to Health Authority questions
BROCHURE
Meeting global Regulatory requirements with pharmaREADY®
Discover more about our innovative Regulatory technology to drive accelerated compliance and deliver first-time-right solutions
BROCHURE
Achieving RIM excellence with rimREADY®
Learn more about our innovative technology to simplify RIM operations and enable accurate and timely submissions
ARTICLE
Electronic Automation and Process Optimization for First-Time-Right Submissions
Learn more about reducing the approval timeline and getting to market as early as possible
Partner with Navitas Life Sciences
Our CMC management services are designed to ensure compliance and streamline your regulatory processes. By partnering with Navitas Life Sciences, you gain access to a team dedicated to delivering high-quality, timely, and accurate support tailored to your specific needs.
BLOGS
How to provide ‘Outstanding’ Regulatory Compliance Services to a Top 10 global pharma
Learn more about our a leading global pharma company commended our support highlighting our collaborative approach and teamwork in the successful migration of regulatory files.