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