HingeClinica providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and medical devices.
- CTD/eCTD Submission
- Submissions of CTAs
- Review and compilation of Product Registration dossiers (NDA/MAA/ANDA, IND/CTA, DMF)
- Life Cycle Management of Annual Reports, Variations, Renewals, Safety Reports
- 510 K Submissions
- PMA Submission
- Preparation and review of T-License, Import/Export dossiers
- Responses to regulatory authorities or review of deficiency responses.
- Submissions eCTDs for IND/CTA, NDA/MAA, ANDA
- Regulatory Agency Liaison
- DMF compilation for Submission to EU and USFDA in CTD format
- GMP compliance services for APIs and finished manufacturing facilities