Regulatory affairs services

We offer multidisciplinary services covering all aspects of regulatory affairs including pre-authorisation, post-authorisation as well as handling of registration process of medicinal products (human/veterinary) and medical devices across all application types and various pharmaceutical forms. We can also support you in placing dietary supplements or cosmetics on a market.

• Originals (including biotechnological drug products)
• Generics
• Biosimilars
• Hybrids
• Well Established Use, WEU
• Fixed Drug Combination, FDC
• Traditional herbal medicinal products

We offer our assistance in planning and implementation of a regulatory strategy complying with all the requirements throughout the product lifecycle. Our experienced and highly-qualified team may help you to solve even the most complex regulatory issue finding the most convenient solution.