PharmaLex has an experienced team of regulatory experts in Chemistry, Manufacturing and Controls (CMC) and pharmaceutical quality and we are ready to assist you! We have extensive expertise in developing CMC strategies, working with CMO vendors and we are prepared to author, review and revise CMC documentation in collaboration with your specialists from production, quality control, regulatory affairs and pharmaceutical development. We can do so from anywhere (our office or yours) and for any health agency in the world.
We seamlessly coordinate with your specialists and safeguard regulatory compliance from pre-IND through the product life cycle. Whether it is a first-time submission, change control, or post-approval maintenance, our multi-disciplinary teams take responsibility for technical writing, regulatory strategy, GxP, and agency submissions on a local or global basis. We perform gap analyses on your existing documentation and advise of any additional requirements you may have missed.
CMC Consulting services include:
- CMC regulatory strategy, including critical review and assessment of the drug substance / active pharmaceutical ingredient (synthetic or semi-synthetic small molecule, natural product, peptide), drug product dosage form (tablet, capsule, patch, cream, wafer, solution, injectable, inhalation aerosols and sprays, biologic product), and Quality modules (Module 2: Quality Overall Summary (QOS) and Module 3: Quality) of the Common Technical Document (CTD) for regulatory submissions.
- CMC document authoring or critical review prior to regulatory submission.
- DMF/EDMF preparation and maintenance
- Certificate of suitability
- CMC portions of IND and NDA/BLA, Market Authorization Applications (Module 2 and 3)
- CMC Technical Advice
- Product Characterization
- Process Development
- Pre-formulation and formulation
- Analytical methods
- Technology transfer
- Stability study design
- CMC regulatory gap analyses for identification and assessment of additional data or reports of needed CMC documentation.
- CMC regulatory preparation and participation for FDA or EMA Meetings, including meeting request and briefing book preparation.
- Short term or long term assignments to fill resource gaps or high peak workload periods.
- Outsourcing of routine lifecycle management activities, allowing you to focus on business critical activities.
- CMC regulatory problem solving related to active pharmaceutical ingredient, drug product, dosage form, biological, contract manufacturing organization or technology transfer.
- CMC regulatory sciences due diligence for assessment, analysis, summary and recommendations for startups, joint ventures, acquisitions or business partnerships.
- Mitigation strategies for CMC regulatory conformance and compliance.
- Development of compliant regulatory system and processes.
- CMC Quality Management
- cGMP Auditing of manufacturing processes, packaging, and distribution centers
- GMP compliance strategies
- Pre- and post- approval inspections
- QA/QC documentation review
- Batch Records
- Change Control
- Document Management
- Part 11 Compliance
- Interpretation and application of CMC regulatory regulations and guidances for Investigational New Drugs (IND), New Drug Applications (NDA), Biologics License Application (BLA) and Drug Master Files (DMF).
Our experts are continuously updating their skills and knowledge to provide the best understanding, interpretation and utilization of regulatory guidance and regulations. We are on the leading edge of industry and government agency best practices and trends. PharmaLex provides extensive due diligence, anticipating what an agency reviewer will require!