Our Regulatory Affairs department provides a clear path to regulatory approval by ensuring confident, accurate and timely document submissions. Our regulatory team has up to 20 years of experience across all therapeutic area, phases and industries. We support marketing authorisation application across the product lifecycle, including market access and promotional material compliance.
We leverage flexibility, experience in multidisciplinary projects, excellent relationships with health authorities and deep knowledge of the regulatory environment to ensure that your submission is ready for review and timely conclusion.
Our clinical trial services take you from initiation to follow-up to completion. They include:
Our marketing authoriation and post-marketing authorisation services include:
We have experience with clinical studies across therapeutic areas, phases and industries: