Drug Development Services and Pharma Regulatory Affairs

Consulting for Clinical Drug Development and Pharma Regulatory Affairs

Demonstrating early evidence of clinical effect and tolerance in humans is a critical step for your drug’s successful development. Our Drug Development Consulting and Pharma Regulatory Affairs team helps you navigate the complex process of initiating clinical studies and planning development strategy based on results. Our professionals have industry-tested experience in getting drugs approved so you can get your products to market faster.

Our Integrated Approach

Integrated drug development requires a multidisciplinary approach to understand how manufacturing, pharmacology and toxicology contribute to regulatory strategy and to elements of clinical study design and conduct. The knowledge and leadership of our highly trained scientists significantly streamline the early clinical development process, enabling you to minimize costs and make more informed decisions. Our integrated services span small and large molecule drugs, vaccines, and other therapies, from preclinical testing through clinical proof-of-concept all the way to full clinical development.

Multifaceted Consulting Expertise

Our drug development experts conduct gap analysis and provide technical advice in specific therapeutic areas, such as metabolic (diabetes, obesity, NASH) and respiratory (cystic fibrosis, COPD, asthma) conditions, as well as for vaccines and biosimilars. We also recruit, organize and conduct advisory meetings to enable you to carry out comprehensive development strategies. Clients regularly tap our clinical pharmacology expertise and clinic capacity to design and execute efficient, timely packages of studies that support drug product labeling, including drug-drug interactions (metabolic and transporter), PK in patients with hepatic or renal insufficiency, ADME, and market product bioequivalence.

Our experienced global regulatory team helps you plan and execute practical regulatory strategy with tactical support to meet your objectives, ensure high-quality regulatory documentation and timely communication with regulatory agencies.

• Our experienced leadership in clinical pharmacology and early clinical development enables us to provide you with meaningful information for critical development decisions.
• We leverage our knowledge of and access to safety and effect biomarkers to understand how your drug is working in humans, early in the drug development process.
• We are a global leader in planning and conducting efficient, timely packages of clinical pharmacology studies to support product labeling, driven by our experience performing hundreds of such studies.