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 authorisation and post-marketing authorisation services include:
Our Quality Assurance department provides a clear path to maintaining compliance in the face of increasing regulatory scrutiny. Our team has dozens of years of experience on GxP regulated activities. We provide QA services to local and multinational pharmaceutical companies, medical devices companies, global CROs and medical associations.
We offer simplified reporting, easier audit preparation, improved document management and increased visibility across all processes to deliver quality management you can count on.
Our Quality Assurance services include:
For MAH:
For clinical trials:
