Delivering sound regulatory strategies and operational support for drug and device development.
In today’s complex environment, our regulatory professionals have the experience and knowledge to support you through the entire product lifecycle. 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.
Regulatory strategies and services for biotech, pharma, device companies and the research, investment, and legal firms that support them.
Clinical trial support
Consulting and operational services to ensure that your clinical trial is aligned with the latest regulatory agency developments.
Our full range of strategic and operational regulatory services include support for:
Our regulatory professionals have broad therapeutic expertise and experience. We also engage with an established network of international consultants.
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. We pride ourselves in delivering a world class service to pre-agreed timeframes.
Stay current on the latest country, regional and global regulatory changes.
Regulatory Intelligence newsletter
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COVID-19 regulatory updates
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The IVDR and 2022 deadlines
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