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Regulatory affairs

Regulatory affairs

Led by a team of regulatory affairs consultants, with knowledge and expertise to support Sponsors through the pre and post marketing drug regulations and in all stages of drug development.

Our experience in all aspects of the clinical trials submission process (IRBs/ECs and EMA authorities) will ensure smooth compliance at every phase of the trial.

Highly qualified regulatory staff, medical writers, data managers, and statisticians work together with your team to ensure the clinical, scientific, and regulatory integrity of every project from submission through to marketing, application submission and regulatory review.

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