Consultants reviewing a nonclinical strategy document in a meeting room

Services for every stage of development.

Tailored projects or ongoing support, with scope and deliverables defined in the proposal.

01

Evidence-driven nonclinical strategy

Pharma and biotech

Planning of the nonclinical program from existing data, with judicious use of NAMs and in silico approaches, through to defining the assays that are truly needed.

See the complete approach

Deliverables

  • Existing data assessment and data gap analysis
  • Study roadmap (what to run, what to waive, in what order)
  • Minimum evidence package for FIH
  • Laboratory guidance and oversight of studies at CROs

02

Study waiver justifications

Pharma and biotech

Technical and scientific rationales to waive studies when existing evidence already answers the regulatory question.

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Deliverables

  • Feasibility assessment
  • Justification document with traceable references
  • Support in responding to agency questions

03

Nonclinical writing

Pharma and biotech

Writing of the documents that take a drug candidate to the clinic, with pharmacology, pharmacokinetics and toxicology data organized into a clear and consistent narrative.

Deliverables

  • CTD Module 2.4 (Nonclinical Overview)
  • CTD Module 2.6 (written and tabulated summaries)
  • Nonclinical study reports
  • Technical review and quality control of documents

04

Toxicological assessment of products

Pharma, biotech, cosmetics and ingredients

Safety assessment of medicines, finished products, ingredients and molecules, based on a critical review of the literature and the applicable regulatory requirements.

Deliverables

  • Toxicological profile of substances and ingredients
  • Safety assessment of finished products
  • CPSR (Parts A and B) and PIF support, for cosmetics
  • Documentation for ANVISA submissions

Ongoing support · Pharma and biotech

A toxicologist alongside your program.

Fractional toxicologist (on demand)

A monthly package of hours for pharmaceutical and biotechnology companies without a toxicologist on the team, or with demand above internal capacity.

Includes

  • Answers to technical and regulatory questions
  • Review of protocols, test reports and study reports
  • Oversight of studies at CROs
  • Updates to regulatory documents

NAMs radar applied to the portfolio

A quarterly report that cross-references regulatory news on NAMs (OECD, FDA, EMA, ANVISA) with the client’s projects and indicates which planned studies could be replaced, reduced or waived.

Includes

  • Customized quarterly report
  • Meeting to discuss the findings
  • Ad hoc alerts on relevant changes

Cosmetics and ingredients

Cosmetic safety

CPSR, PIF and documentation for ANVISA.

Animal-free testing strategies

Eye and skin irritation and sensitization, based on OECD guidelines.

Hazard communication

GHS classification and Safety Data Sheets (SDS).

We also work on

Claims and scientific communication
Claim substantiation for labels and marketing, technical materials, white papers and articles.
Manuscripts and funding proposals
Scientific writing for publications and funding calls.
Consulting for NAM developers
Context of use, qualification plan and regulatory pathway for new methods, including 3D models and organ-on-chip.
In-company training
NAMs, in vitro toxicology, reproductive toxicology and hazard communication.

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