Pharmacology & Toxicology studies
Independent coordination, analysis, and communication of toxicology and pharmacology results for regulatory and funding decisions.
Advanced Toxicology & Pharmacology evaluation and positioning
From safety data to defensible regulatory and funding evidence.
Interpreting non-clinical toxicology outcomes requires more than technical review. It requires in-depth understanding of the disease area, therapeutic mechanism, and regulatory context.
PROMAFUN CRIO supports organisations in analysing, interpreting, and positioning toxicology and pharmacology data in ways that withstand regulatory, investor, and partner scrutiny.
Our focus is not only on data quality, but on decision relevance.
Why
Scientific Interpretation Matters
Toxicology findings influence:
• Regulatory approval pathways
• Clinical transition decisions
• Investor assessments
• Partner negotiations
Without proper interpretation and positioning, studies risk being:
• Technically correct but strategically weak
• Misaligned with regulatory expectations
• Difficult to defend externally
Outcome:
Reduced credibility and increased development risk.
Our Role
We combine scientific expertise with regulatory and strategic insight to ensure that toxicology data is interpreted in its full clinical and development context.
We support organisation by:
• Reviewing study outcomes independently
• Interpreting findings against mechanism of action
• Assessing clinical and regulatory relevance
• Identifying development risks early
Outcome:
Your results are understood, not just reported.
Services we provide
Study Strategy & Toxicology Package Planning
We advise on the design of comprehensive toxicology programmes, including:
• Single and repeat dose toxicity
• Genotoxicity and carcinogenicity
• Developmental and reproductive toxicity
• Safety pharmacology
• Toxicokinetics
All aligned with compound class and clinical development plans.
Outcome:
Your safety package support regulatory and clinical progression.
Regulatory Alignment & Submission Support
We support :
• Protocol development and review
• IND/CTA preparation
• NDA/MAA module alignment
• Pre-submission gap analysis
• Regulatory consultation preparation
Outcome: Reduced regulatory uncertainty and review risk.
GLP Quality Oversight
We ensure that studies meet Good Laboratory Practice requirements through:
• Study design review
• Execution monitoring
• Documentation assessment
• Quality system alignment
Outcome: Increased likelihood of regulatory acceptance.
Data Interpretation & Risk Communication
We translate technical results into decision-ready insights, including:
• Organ-specific effects
• Dose-response relashionships
• NOAEL and MTD determination
• Risk-benefit positioning
Outcome: Your data can be communicated credibly to regulators, investors, and partners.
Monitoring & Reporting
We assist projects in establishing and tracking dissemination indicators, and in preparing documentation for reporting and review.
Our work includes:
• Definition of dissemination and KPIs
• Tracking outputs, reach, and engagement
• Contributions to periodic and final reports
• Preparation of supporting documentation for audits and evaluations
Outcome: Your dissemination activities are transparent, measurable, and documented in accordance with funder expectations.
Integrated Stakeholder Reporting
We support the preparation of integrated reports that connect:
• Scientific findings
• Mechanism of action
• Risk mitigation strategies
• Clinical development pathways
These reports are designed for:
• Regulatory agencies
• Funding bodies
• Strategic partners
• Internal governance
Outcome: Consistent, high-quality communication across stakeholders.
Who We Work With
Toxicology and pharmacology coordination is relevant for organisations that are advancing scientific programmes and require defensible safety data in regulated and competitive environments.
We typically support:
• Biotech and life science startups: building preclinical evidence and preparing for first major safety packages.
• Scale-ups and SMEs: managing complex toxicology portfolios across products or indications
• Academic research groups: translating preclinical data into fundable and regulatory-relevant evidence
• Clinical development leads: preparing for IND/CTA submissions and regulatory interactions
• Project coordinators and managers: needing alignment between study execution, reporting, frameworks, and stakeholders expectations
• Consortium leads: integrating safety data across partners to strengthen collective position
These groups engage us when internal capacity is limited, when independent evaluation is needed, or when strategic alignment of study design and reporting is essential for regulatory or funding outcomes.
Outcome: Credible and Defensible Development Evidence
Through integrated scientific review, regulatory alignment, and strategic communication, we ensure that toxicology and pharmacology data is:
• Scientificall robust
• Regulatory compliant
• Strategically positioned
• Externally defensible
This strenghtens your position in regulatory, funding, and partnership processes.
Start with a Scientific Review Consultation
If you are preparing, reviewing, or interpreting toxicology or pharmacology studies, we invite you to schedule an introductory consultation.
Contact Form
Have a question about our Toxicology services? Want a feasibiligy assessement, quote, or collaboration? Please fill out the form below and our team will get back to you within 1-2 business days.