Delivering sound regulatory strategies and operational support for drug and device development.
Our extensive experience with the FDA, EMA, European and international regulatory authorities allows us to deliver strategic and operational support to expedite your drug and device development programs across the entire product lifecycle.
Regulatory strategy
Regulatory strategies and services for biotech, pharma, device companies and the research, investment, and legal firms that support them.
Global and local regulatory insights
We continuously monitor today’s complex and ever-changing global regulatory landscape to efficiently deliver quality regulatory services and submissions. By staying ahead of all current legislation, guidelines, and other regulatory intelligence, we can advise you across all aspects of the development process, including the maintenance of marketed products. Our global presence enables us to bring a deep understanding of local regulatory requirements to every project, keeping your research on time and on budget.
A full-service regulatory partner
- Regulatory project management and submissions
- Regulatory technology and information management
- Labelling, including content development, project management, document review and compliance
- Medical writing, quality control and editing services
- Regulatory CMC to ensure practices are compliant with global requirements
- Clinical trial transparency including complete trial disclosure lifecycle management
Our full range of strategic and operational regulatory services include support for:
- Advanced therapy medical products (ATMPs)
- Biosimilars
- Biologics and biotech products
- Combination products
- Genetically modified organisms (GMOs)
- New chemical entities (NCEs)
- Medical devices and diagnostics
- Rare and orphan drugs
- Vaccines
Customised solutions
The focus is always on designing a package of services to meet your organisation's needs and study requirements. Teams located in offices across the globe enable us to provide you with the right service, at the right time, according to your specific clinical development plan.
Our combined industry and CRO experience, in all phases of clinical development and commercialisation and in all major clinical indications, allows us to provide expert regulatory project management and consultancy services to meet your complex and evolving needs.
Regulatory insights
Stay current on the latest country, regional and global regulatory changes.
EMA guideline on computerised systems and electronic data in clinical trials
This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.
Procedural and regulatory know-how for China biotechs in the EU
ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA.
Regulatory Intelligence newsletter
Our monthly newsletter will keep you abreast of global regulatory changes that could impact your product. Subscribe today.
Regulatory considerations for biotech
The importance of regulatory affairs when developing an asset and considering a drug development partner.
The IVDR and 2022 deadlines
Be prepared for a successful transition. Read our whitepaper.