We help clients move their projects
through the drug development arc.

Drawing from a deep knowledge of toxicology, ADME Pharmacokinetics and Preclinical Regulatory Strategies, we leverage our wide scope of expertise with various therapeutic disease targets and types of compounds.

• 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.