Our Services

The pragmatic Nonclinical Safety Assessment Consultant for the Biopharmaceutical  Industry


Nonclinical Strategic Advice and Interim Management

Competent, affordable and uncomplicated support for your start as a biotech company.

Toxicology Consulting for the Biopharmaceutical Industry

Create additional capacities and gain specific skills from an experienced Nonclinical Safety Expert

Nonclinical Safety Assessments

Toxicological Risk Assessments

Strategic input to Nonclinical Development Programs

  • Preparation of Nonclinical Development Plans
  • Estimation of Overall Budget and Timelines
  • Definiton of a Translational Approach with
    Mode of Action- and Safety-related readouts
  • Regulatory Strategy (Scientific Advice etc.)
  • Gap Analysis
  • Building / Leading your Nonclinical Department
  • Alignment with other Departments
  • Life-Cycle Management
  • Change of Formulation or Route of Administration
  • Extension of Therapeutic Indication

Implementation of Nonclinical Development Plans

  • Being your Toxicology Consultant on demand
  • Being a member of your Development Team
  • Filling in for transient lack of capacity or expertise
  • Interim-Management
  • CRO Selection, CRO Management
  • Study Monitoring
  • Filling in for reduction of headcount, extended illness, increased workload, maternity leave, etc.


Nonclinical Development of Biopharmaceuticals & ATMPs

  • Justification of Relevant Species
  • Selection of suitable CROs and Vendor Oversight
  • Management of CRO activities
  • Tracking Study Milestones and Timelines
  • Planing, Placing, Monitoring and Finalization of
    Nonclinical GLP and non-GLP Studies
  • Data Review
  • Issue Management

Nonclinical Safety Assessments

  • Study Planning, Study Monitoring
  • Report Finalization to ensure clarity, alignment with project goals and compliance with regulatory requirements
  • Benefit-Risk Evaluations
  • Justification of Relevant Species
  • Justification of MRSD/FIH
  • Justification of Clinical Dose Escalation


Regulatory Writing

  • Scientific Advice Briefing Books
  • Submission Documents like IND / IB / MAA / BLA
  • Responses to Deficiency Lists
  • Justification / Waiver for Paediatric Investigation Plans
  • Justification / Waiver for Combination Toxicology Studies

Toxicological Risk Assessments

  • Impurities
  • Excipients (due to Formulation Change)
  • Extractables & Leachables (Combination Products)
  • Justificaton for PDE Values

Other Services

  • Due Diligence
  • Sparring Partner for Project Evaluations
  • Setup of a fit-for-purpose non-clinical SOP system

Nonclinical Study Monitoring

  • NCMA Consulting offers study monitoring at European sites of CROs for both GLP and non-GLP studies
  • NCMA Consulting is located in the centre of Europe and can reach any European CRO at acceptable costs.


  • Being on-site for critical study phases
  • Being your eyes and ears to assure that quality studies are conducted
  • Monitor study conduct and execution
  • Monitor data collection and data handling