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By Stage of Drug Development

Pre-Clinical

Pre-Clinical Development Determine the safe dose for FIH study Early-Stage Clinical Development Assess efficacy, effectiveness and safety Late-Stage Clinical Development Gather data for registration and market access Registration Assemble and file an application Commercialization & Post-Launch Post-approval regulatory, lifecycle management

Determine the safe dose for FIH study.

Preclinical development enables drug candidates to progress from research to development, by linking discovery in the laboratory to testing in humans. Analytical methodology and manufacturing processes are established and ramp up towards GMP compliance to support initial clinical trials. The product pharmacology, pharmacokinetic/ biodistribution, and toxicity profiles are explored, which ultimately aim to support the intended clinical trial design for first-in-human testing.

Client Goals

People - VCLS

Understand the market potential

Identify the path to market and outline a high-level development plan.

Therapeutic indication

Define optimal clinical indication

Outline a preliminary Target Product Profile (TPP), including commercial and clinical considerations.

Clinical studies

Design and conduct preclinical studies, analytical and manufacturing process

Define pre-clinical data necessary to enter the clinic. Identify predictive models and alternatives to animal testing.

Strategy planning

Set up the overall product development plan

Develop analytical methodology and manufacturing processes Identify product-related risks to be assessed and managed.

Stage of development: challenges

CHALLENGES

  • For which indication to first develop the product?
  • Is there an animal model and how relevant is it?
  • Will the overall nonclinical program support the intended First-In-Man clinical trial?
  • Is the manufacturing process adapted/able for future clinical development?
  • Are all analytical methods necessary at this stage in place to assess quality?
  • How realistic is the overall product development plan?
  • What is the product time-to-launch?

Our mission

Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets.

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What VCLS Can Do

What VCLS Can Do - Services

VCLS Expertise