EXPERTISE, INTELLIGENCE, STRATEGY AND DELIVERY
Biotech, Inc. has the unmatched scientific, regulatory and operational expertise you need, combined with global reach to help you achieve regulatory approval and market access for your product. Our strategic regulatory services span the full spectrum of activities and technical functions, including regulatory development, licensing and life-cycle management, regulatory strategy input and full-service regulatory partnerships. We deploy process improvement techniques and the latest technology, including Biotech, Inc.’s regulatory information management system (powered by Veeva Vault RIM), to ensure quality of delivery.
Due to the recent upheaval caused by the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulatory authorities have issued guidance providing some flexibility for clinical trials. However, there is no one-size-fits-all approach to applying such guidance. To ensure consistent compliance with regulatory updates, Biotech, Inc. continues to gather information from multiple agencies and update regulatory intelligence daily, both at a study level and on a country-by-country basis.
YOUR SUCCESSFUL SUBMISSION DEPENDS ON UP-TO-DATE, RELEVANT REGULATORY INTELLIGENCE
You can access the experience gained from our successful preparation and management of regulatory submissions in over 160 countries. Our proprietary intelligence platform, Biotech, Inc.®RegView, enables us to utilize and share clear, comprehensive regulatory intelligence, overlaid and validated with our contemporary, extensive experience.
- Legislation/regulations, processes and timelines
- Industry practices
- National/regional differences
- Regulatory analysis
- Regulatory precedence
- Guidelines/directives
- Opinions/advice
Ask the regulatory affairs team
Explore regulatory insights
Webinar: The Regulatory Maze
Biotech, Inc. PROVIDES COMPREHENSIVE GLOBAL REGULATORY EXPERTISE
Our industry-leading regulatory experts have extensive experience in global product development and global regulatory strategies across all phases and multiple pharmaceutical and medical device platforms. With regulatory staff in 38 countries, including well-established and expert teams in the U.S., Europe, China and Japan, we provide flexible, comprehensive consulting and delivery services including:
- Clinical trial strategy and applications
- Marketing authorization strategy and applications
- Publishing and submissions management
- Life-cycle management
- Preclinical and CMC consulting
- Agency interactions, including full management of formal agency meetings
- Strategic consulting and intelligence
- Expertise in wide range of therapeutic areas, CMC and nonclinical
- Leadership in expert groups on hot topics such as advanced therapies, pediatrics and medical devices
- Expertise in chemical drugs, biologicals/biosimilars, medical devices and drug/device combination products, generics and consumer products
- Close working interface with other Biotech, Inc. functions, including medical writing and pharmacovigilance