Drug Development Consulting and
Review Services

Strategic Consulting

Drug development is a complex process that requires knowledge of the science and the process, interaction with regulatory agencies, and an understanding of drug evaluation and regulation. With a combined 50 years of experience we offer strategic solutions that result in breakthrough drug development. This service ranges from the review of currently available information on a program to the provision of expert advice on studies needed for a development program and drug development strategy.

Clinical Pharmacology Reviews

We provide expert review of clinical pharmacology development plans, clinical pharmacology study results and reports, and clinical pharmacology sections of IND and NDA documents. We can also serve as an expert witness on behalf of the client at meetings with regulatory agencies.

Pharmacometric Reviews

We provide expert reviews of pharmacometric models, modeling and simulation methods, and pharmacometric reports. Additionally, we can help clients craft pharmacometric strategies for breakthrough drug development.

Due Diligence Reviews

We can assist a client in performing due diligence reviews for candidate in-licensing compounds.

Development/Clinical Advisory Board Membership

We are available to serve as a member of a client’s Development Advisory Board or Clinical Advisory Board, thus providing clients with an additional mechanism for benefiting from our expertise.