Services
Regulatory Strategy
Our dedicated team offers regulatory, medical, and operations expertise to assist our clients in meeting regulatory standards to receive product approval.
In the highly regulated environment of drug development, it is important to evaluate regulatory pathways and obtain buy-in from governing regulatory bodies as early as possible. This ensures speed to market and minimizes the potential for delays.
Our qualified professionals bring a depth of expertise in managing clinical trials, from protocol design to site receipt of clinical materials. This global expertise combined with an understanding of local requirements and regulations, language proficiency and established working relationships with key logistics parties across the supply chain, allow us to support the regulatory-compliant movement, management and delivery of supplies to the globe across all therapeutic indications.
Our experts have served on US Food and Drug Administration (FDA) Advisory Panels, Medicines and Healthcare Products Regulatory Agency (MHRA), and the World Health Organization (WHO) advisory panel. They continue to frequently meet with regulatory authorities (FDA, European Medicines Agency [EMA], and many others) to discuss our sponsor’s products, regulatory strategies, and innovative pathway designs, minimizing the risk of study delays and clinical holds due to unforeseen regulatory issues.
Examples of our interactions with regulatory authorities includes: Clinical development planning meetings; End of phase II meetings; Pre-Investigational New Drug (Pre-IND); Pre-Biologic License Application (Pre-BLA); and Pre-New Drug Application (Pre-NDA) meetings; Scientific advice meetings; and Regulatory authority sponsored public workshops.
Do you have a product that need our expertise or requires international regulatory approval?
Get in touch with our expert team
Contact us
Clarendon House
52 Cornmarket Street
Oxford , OX1 3HJ
Phone number: +44 (0)1865 304096
Email: info@oxfordmedwell.uk
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