Regulatory Consulting – HingeClinica

HingeClinica providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and medical devices.

Regulatory Services:
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

Regulatory Services:

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