The decisions you make about Pharmaceutical Regulatory Affairs can fuel your growth, or create unnecessary obstacles between you and your objectives. CGS has access to a broad network of RA experts within and outside the EU. These experts will be involved in case of country/ region / specific requests or requests for which other specific expertise is required.
Initially launching your medicinal product in one country can speed up its launch in another, but it might potentially affect your pricing in other countries, or across an entire market! That means successfully navigating regulatory requirements is more than simply following the rules, it’s about understanding the complexities and implications of different procedures and requirements across world markets and developing the best strategy for your current and future needs around them.
It doesn’t matter if you’re a US-based biotech looking to reach specific or all markets, or you’re a more established European company needing guidance for OTC authorization, wherever you are and your target market is, we can make sure you can achieve your goals faster, better, smarter. Our experts are involved in the regulatory procedures for a wide variety of drugs and medical devices and is fully acquainted with the EU Directives involved. The company supports or advices on the regulatory processes including:
CGS is familiar with the documentation required for the regulatory processes, including nonclinical, clinical and pharmaceutical overviews and technical files. Other areas of the company’s expertise are clinical trial applications and reimbursement procedures for pharmaceuticals as well as vigilance programs for drugs or medical devices.
