Non-Clinical Assessment & Management

Fulcrum's non-clinical development specialists have expertise in efficacy and safety pharmacology, PK/PD, ADME, and toxicology.  Fulcrum works with clients to design and implement non-clinical development strategies and plans that:

• Meet the corporate goals of the client
• Meet regulatory requirements
• Support clinical development plans
• Support product registration

We collaborate with our CMC, regulatory, QA and clinical specialists to ensure that non-clinical development plans provide the most time-efficient and cost-effective strategy for clients.  

Our non-clinical services include:

• Development plans and study design
• Supplier selection, study execution, and contract management for:
  • Pharmacology
  • Safety pharmacology
  • ADME
  • Toxicology
• Interactions with regulatory authorities
• Preparation of pharmacology, pharmacokinetic and toxicology sections for regulatory submissions such as INDs, CTAs, NDAs and BLAs
• Representation at Agency meetings (pre-IND, end of Phase II)
• Review and consultation on non-clinical and regulatory issues affecting submissions
• Preparation of regulatory submission amendments and supplements
• GLP compliance audits
  

Download Non-Clinical brochure

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