Advisory & Regulatory2020-04-20T15:05:29+00:00

Advisory & Regulatory

Clinilabs Drug Development Corporation provides advisory services that merge our therapeutic area and commercial expertise to support global CNS drug development programs and drug lifecycle management. We combine our scientific and operational understanding of CNS drug development with our knowledge of healthcare delivery to help our customers launch products with the greatest potential for commercial success.  We merge our senior advisors with external (consulting) subject matter experts to create advisory teams able to get to the heart of our customer needs. We offer perspectives from a diverse panel of individuals from industry, academia, and clinical medicine to offer customers actionable insights and solutions. Through the strength of our personalized approach, we provide the resources to develop strategic approaches to asset development.

Regulatory services are among the most important elements of support needed by small- to mid-sized drug companies. Clinilabs works with trusted partners worldwide to support clinical and regulatory activities in the U.S., European Union, and emerging markets. This includes regulatory guidance for the development of new chemical entities, the execution of multinational clinical trials, and the evaluation of previously marketed products. The expertise we provide in CNS therapeutics enables our customers to make informed decisions regarding drug development plans and regional applications for marketing drug products. The teams we assemble have extensive experience in multinational filings, offering a competitive benefit to customers who do not have in-house regulatory functions. We are pleased to offer second opinions regarding regulatory matters.

Protocol design and program development

Clinilabs maintains a Scientific Advisory Board that is prepared to provide protocol development and program development advice to sponsors.  The members of our SAB are subject-matter experts who are highly regarded in their respective fields, and many are considered key opinion leaders (KoLs).  Our advisors enable us to deliver scientific advice to sponsors developing drugs in the CNS therapeutic area.

IND Applications and Translational medicine

Clinilabs maintains relationships with a small group of advisors who have expertise in translational medicine.  These individuals evaluate pre-clinical data to assist in the development of IND applications, investigator brochures, and clinical development programs.

Regulatory Services

Clinilabs provides support for the development of INDs, as well as regulatory filings in the EU.

If you think compliance is expensive, try non-compliance.

– Former US Attorney General Paul McNulty