Regulatory Affairs
Life Sciences Expertise
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.
Our assets:
- 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?
Quality-Driven
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.
Customer-Focused
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.