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Fewer studies.
The right studies.

D-Sci Consulting builds nonclinical strategies from the data that already exist, with non-animal methods and in silico approaches where applicable, and turns the result into documentation ready for the FDA, ANVISA and the European Union.

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PhD

Technical content authored by a PhD in Pharmaceutical Sciences

Pre-IND / IND

Drafting of CTD nonclinical modules for FDA submissions

Remote

Meetings and documents in English or Portuguese

From existing evidence
to the dossier.

  1. 1 Existing data
  2. 2 In silico and read-across
  3. 3 Gaps and assays
  4. 4 Study oversight
  5. 5 Regulatory documentation
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From the lab to the first dose in humans, with the right evidence.

We define the minimum set of nonclinical evidence needed for first-in-human (FIH) administration, building on published data and qualified non-animal methods. Fewer redundant studies, less animal use and a shorter path to the clinic, with a solid scientific rationale for the agencies.

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What we do.

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Whoever understands the data writes the document.

  1. Data and document, together.

    Study interpretation and regulatory writing are handled as one task, so every conclusion in the dossier traces back to how the data were generated.

  2. NAMs with both feet on the ground.

    We use non-animal methods where they answer the regulatory question, and we say clearly when a traditional study is still needed.

  3. Focus on cost and timeline.

    Every study waived or better designed is time and investment saved in your program.

Published in the specialist press.

Have a program on its way to the clinic?

Tell us about your challenge and receive a tailored proposal.

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