Granzer Regulatory Consulting & Services provides a full range of regulatory CMC support throughout the entire drug development process, which is integrated with our other services for regulatory strategy, project management and regulatory procedures, devices, and eCTD publishing.
We help our clients define their global regulatory CMC strategy and plan the timelines for their clinical studies and marketing applications, taking a phase-appropriate approach for authoring of IMPDs and INDs and later MAAs, NDAs and BLAs.
If we are not involved in development from the early stages, we often join projects by responding to demanding information requests from authorities, performing due diligence or gap analyses, and providing technical/regulatory troubleshooting. This usually leads to discussions with the authorities in Scientific Advice or similar meetings, which is one of our most frequent tasks.
Our consultants collaborate with colleagues from Granzer Pharmaceutical Services to support GMP audits, import/storage of investigational products and QP services.
We support you with:
- Global regulatory CMC strategy
- Due diligence and gap analyses
- CMC development support and troubleshooting
- Preparation of quality related parts of briefing packages and representing the sponsor in scientific advice meetings
- Phase appropriate preparation of IMPD and quality related IND modules
- Responses to information requests in clinical studies
- Preparation of quality related modules (M2.3 & M3) for NDA/BLA & MAA
