Regulatory Affairs
Regulatory affairs serve a critical function throughout a healthcare product's life cycle. From development to market launch and throughout the marketing process, it is a major challenge for industrial companies.
Medicines / Pharmaceutical expertise
HCS ensures the compilation and submission of all files (MA, QR, variation, and others) to national and international authorities (export countries). It can also be entrusted to officially ensure the follow-up until the MA (or CE) is obtained.
Proposal and implementation of a technical-regulatory and market access strategy
Contact with the competent authorities and management of responses to questions
Regulatory audit and evaluation of CTD files (gap-analysis)
Reaction and update of Module 3
Expert report writing: quality (module 2.3.QOS), pre-clinical (module 2.4) and clinical (module 2.5)
Preparation and compilation of CTD and eCTD files
Management and submission of local and export registration procedures
Refund files
Customized regulatory monitoring
Audit and scientific due diligence, technical-regulatory and organizational
Medical Devices / Cosmetics / Food Supplements / Reagents
Declaration of medical devices, food supplements, cosmetics and reagents companies
Support and preparation of registration dossiers
Submission and follow-up of all registration files until the registration certificate is obtained
Regulatory Intelligence