Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

Other Drug Development Consulting Services

Drug Development Consulting

Getting a new drug or biologic from the bench to market is a multi-year process involving numerous Quality (CMC), Safety (Nonclinical), and Efficacy (Clinical) studies, each with a set of regulatory requirements that must be achieved.

Drug Development Plans

IMPACT’s experts work with you to design a drug development plan that meets the current regulatory standards and aligns with the most up-to-date thinking of Regulatory Agencies. This plan covers all CMC, nonclinical, and clinical requirements and includes detailed cost estimates and timelines.

To assemble a comprehensive drug development plan, the skilled scientists at IMPACT can:

  • Review existing and planned clinical studies to ensure that the proposed strategy is in line with previously-completed studies and other similar development programs
  • Provide brief study synopses detailing the design and rationale of each study in the development plan
  • Identify potential risks in the overall development plan as well as strategies for their mitigation
  • Assess the adequacy of current and planned nonclinical trials
  • Audit compliance to cGLP, cGMP, and cGCP regulations
  • Oversee the CMC program from active pharmaceutical ingredient route development and manufacture, pre-formulation work, formulation development, analytical development, and clinical batch manufacture
  • Provide a project plan documenting the schedule of the proposed studies and their inter-relationships with one another
  • Provide estimated timelines and overall cost projections

Other Drug Development Consulting Services

IMPACT also conducts detailed cross-functional reviews to assess the acceptability of data packages to support successful IND or NDA/BLA submissions.  Based on these reviews, we provide remediation plans that identify any “gaps,” as well as identify what is required to fill them.

In addition, if you require an assessment of in-licensing opportunities, our experienced staff can provide licensing support by reviewing nonclinical, clinical, medical, and/or regulatory documentation to assure that they are scientifically sound and acceptable.

Through these reviews, we help our clients determine the probability of regulatory success, as well as assign value to potential acquisition targets.

Does your team need assistance with your drug development plan? If so, please contact us. We’re happy to discuss your team’s specific needs and hear about where you are in the process.

For specific examples of our drug development consulting services, please check out our case studies and testimonials.