Regulatory Services
Clinigene provides regulatory services to facilitate all stages of drug development. We accomplish this by providing interdisciplinary strategy planning to obtain the most effective and efficient regulatory pathway towards required regulatory authorizations. Our experience in handling a wide variety of regulatory challenges help sponsors in meeting challenging timelines and budget expectations. Work flow, process, and SOPs are designed to provide cost effective and efficient project management solutions towards regulatory authorizations. Our ability to assist sponsors in obtaining appropriate approvals is supported by a deep understanding of and experience in dealing with the complexities of Indian regulations. We are capable of providing services as complete and stand-alone consultancy.
Expertise
- New chemical entities
- New biological entities
- Generics / Biosimilars (rDNA products)
- Monoclonal antibodies
- Stem cells
- Medical devices
- New route of administration
- Diagnostic kits
Services
Marketing:
- Registration of products in India for import, marketing and manufacturing
Clinical:
- Regulatory approvals from Phase I-IV clinical trials including new indications and specialty studies
- Regulatory approvals for conducting BA/BE studies
- Periodic safety update reporting
- Labeling of clinical trial supplies
- Authorizations for export/import of drugs/biological samples for testing
Non-clinical:
- GLP compliant study monitoring & coordination, protocol development & review, regulatory approvals (Recombinant products) and report review
- Complete support to clients for conducting GLP regulatory toxicology studies (in GLP accredited lab)
Discovery:
- Import/export of recombinant clones, cell lines, diagnostic kits, test drugs, etc.
- Regulatory dossier compilation, including CTD and eCTD format
- Strategies on global CTD and eCTD regulatory submissions that conform to FDA and ICH guidelines
|
