We provide experienced regulatory strategic planning, full clinical trial services, regulatory and medical writing, and quality assurance from initial regulatory strategy to submission for market approval. We focus on start-up and small to medium drug and biotech companies who lack in-house resources in these areas.

Our expert knowledge in regulatory and GCP requirements has contributed to our success in conducting quality clinical studies in many therapeutic areas including addiction, analgesics, anti-inflammatory, cardiovascular, endocrinology, gastroenterology, neurology, oncology, pediatric ad adult rare diseases, women’s health, and vaccines.