CARBOGEN AMCIS supports our customers through the often complex and confusing regulatory filing process and also assists many clients in the preparation of the critical documentation phase; providing input and guidance to develop an appropriate regulatory strategy.
Our highly experienced Regulatory Affairs section works alongside the development and production departments to ensure that the various degrees of regulation are adhered to. Pharmaceutical laws, quality, safety and efficacy guidelines as well as global and regional health authorities' requirements are met. Our consultants are well-versed across the international markets and specific regional requirements and fully understand the expectations of different territories.
The critical role that our Regulatory Affairs consultants plays in the route from concept to market is underlined by the vast wealth of experience and knowledge of our team.
From Investigational New Drug Application (IND), through New Drug Application (NDA), to commercial, in-market supply of API, our dedicated staff in regulatory affairs has in excess of 50 years of cumulative experience across the business.
I get to apply my broad scientific and industrial background to many challenging regulatory tasks – but the most rewarding part is supporting a company that supplies a number of established and innovative drug substances to the pharmaceutical market.
Ulrich - Manager Regulatory Affairs, Bubendorf