Business & Decision Life Sciences brings Regulatory and Compliance expertise throughout the product life cycle. We have a broad knowledge of the different regulations applicable depending on products specifications, in different domains and countries.
- Strong expertise in specific knowledge: regulations for pharma products, bio products, food products, and registration, licensing life cycle management, regulatory strategy and compliance management.
- Clinical-Market expertise (ethic committees, market specific requirements, target populations), MAA, post-medical devices and healthcare products.
- A deep understanding of market specific regulatory requirements, whether national or international (EMEA, LATAM, FDA).
- Full area of activities and technical functions including regulatory development (writing, review, authority exchanges, submissions MAA submissions.
- Ability to cover all modules on the eCTD.
- Data tools implementation for regulatory purposes.
- Deep comprehension of the different terms used between authorities and laboratories.
Why choose us?
Business & Decision Life Sciences has several years of experience with multiple clients to ensure their products comply with the current manufacturing practices, regulations and legal requirements.
We work closely with our partners to deliver the best RA solutions on time, while keeping up to date with national and international legislation, guidelines and customer practices.