Major Advantages for Companies through Obtaining EU Small and Medium-Sized Enterprise Status
Small and medium-sized enterprises (SMEs) are the backbone of Europe’s economy, representing 99% of all EU businesses. SMEs are often innovative companies2 that require additional support to navigate EU regulatory procedures. The European Commission (EC) recognizes and offers additional support via Regulation (EC) No. 2049/2005. This whitepaper explores product development incentives that are available to SMEs and how companies can obtain SME designation, even if they are headquartered outside of the EU.
Regulatory Considerations for Biotech
Innovative biotech products present a complex regulatory environment. For this reason, a formidable regulatory strategist is a critical member of the…
Basics of Regulatory Strategy
Driving development of drug products from pre-IND through marketing.
Global Clinical Regulatory Services Newsletter
This quarterly eNewsletter will keep you informed of regulatory news and trends as it relates to the clinical development industry and insights from…