Regulatory Services

Regulatory Guidance and Support 

The pharmaceutical industry is characterized by its dynamic nature, with continual shifts in regulatory frameworks and healthcare sectors. This landscape demands expert pharmaceutical regulatory services and guidance throughout the development and registration processes of healthcare products.

With a proficiency in the latest international regulatory changes, our team is dedicated to offering unparalleled support, particularly in the areas of submissions and documentation, as part of our comprehensive pharmaceutical regulatory services.

All our facilities are Certified under EU-GMP standards and act in compliance with US-FDA regulations, in particular:

• our Swiss facility is recognised by the Swissmedic GMP regulation
• our Japan facility is recognised by PMDA
• our French facility is recognised by ANSM GMP (National France Agency for Medicines and Health Products Safety), ANSES (Agency for Food, Environmental and Occupational Health & Safety), and by KFDA (Korea Food and Drug Administration) 
• our German facility enjoy of manufacturing permission according to Medicinal Products Act (Arzneimittelgesetz – AMG).

Regulatory Services

• Continuous monitoring throughout the development process
• Evaluation of regulatory information and documentation for the compilation of a registration dossier according to the highest standards
• Review and evaluation of administrative data 
• Scientific report writing
• Risk assessment reports (e.g., nitrosamines, Elemental Impurities (Q3D))
• Compilation and organisation of data for pre-submission reports/scientific advice
• Designation of regulatory strategy
• Liaising with European regulatory authorities for submissions, RFIs, variations, and renewals 
• Electronic submissions (applications, variations, renewals, deficiency letters from clients/authorities) e-CTD
• Registration of pharmaceutical products through national, mutual recognition, and decentralised procedures

Highlights

• 100+ submissions in Europe 
• 200+ MA (Marketing Authorisation) in more than 20 countries
• Extensive experience with complex application hybrid (10.3) and bibliographic (10a) legal basis 
• e Submissions using EXTEDO’s eCTD manager 
• 20+ scientific advice meetings with European authorities (including EMA)