We provide a variety
of preclinical regulatory services.

Our full-service approach includes developing fully integrated plans across all preclinical disciplines to addressing specific scientific and regulatory questions. Our strategies and reports are designed with an eye on ultimately presenting to the FDA.

• Consult on preclinical regulatory projects for small molecules (new chemical entities) and large molecules (biotherapeutics—peptides, proteins, monoclonal antibodies, nucleotides).
• Create and analyze preclinical development plans and budgets.
• Conduct regulatory gap analysis assessments.
• Perform both in-licensing and out-licensing due diligence reviews.
• Compose and review regulatory documents (study reports and white papers) as well as prepare packages for submissions.
• Manage the preclinical components of various types of submissions (IND, NDA, BLA, PLA).
• Consult with regulatory scientists and agencies on behalf of clients.