Regulatory Services
Our Services/Solutions for Central and Regional Governments of different Countries:
Our Services/Solutions for Central and Regional Governments of different Countries:
Our core regulatory services:
- CTD and eCTD submissions on all types of drug products
- US and Canadian Drug Master file(DMF) for API, Excipients, Packaging Materials
- Certificate of Suitability as per EP (CEP)
- Summary of Product Characteristics (SmPC)
- Periodic Safety Updates (PSUR)
- New Drug Application(NDA)
- Investigational New Drug Application(IND)
- Abbreviated New Drug application (ANDA)
Our other regulatory services:
- Follow-up with MOH till the registration documents are accepted and approval letter is issued
- GMP Audit/Gap Analysis/Gap Closures services.
- Guidance on Filings Variations/Amendment for the registered products
- Guidance on Labelling and advertising of Medicinal Products
- Packaging Material DMF and Excipients Services
- Expert reports on Regulatory Submissions
- Guidance for Planning, Preparation and Delivery of regulatory submissions throughout the product's life cycle with regional perspective.
- Management of PIL, SPC and Physicians Training Materials
- The Management of audits conducted by FDA/EDQM/MHRA and other Regulatory Authorities
- Pre submission Review of Dossiers/CTD and amendments to the same.
- Guidance on CFR Part 11, ISO 13485, CMDR, MDD ,PAL, FMD, ICH and other National and International Regulatory standards/laws/directives
- Advise on preclinical, clinical and manufacturing requirements for product development
- Advice on new drug development, new dosage forms development and new drug combinations.
- Advise on developing protocols and getting grants for BE studies, Clinical Trials and Non Clinical Studies