Our Services

The pragmatic Nonclinical Interim Management & Nonclinical Study Management Consultant for the (Bio-)Pharmaceutical and Medical Device Industry


Nonclinical Strategic Advice and Interim Management

Competent, affordable and uncomplicated support for clearly defined and time-limited projects.

Nonclinical Study Management and Nonclinical Safety Assessments

Create additional capacities and gain specific skills from an experienced Nonclinical Expert for short- or medium-term projects.

Strategic input to Nonclinical Development Programs

  • Building and Leading your Nonclinical Department
  • Elaboration of Nonclinical Development Plans
  • Elaboration of Overall Budget and Timelines
  • Finding the right people for your Nonclinical Department
  • Definiton and Implementation of a Translational Approach with MoA-related readouts
  • Alignment with other Departments
  • Life-Cycle Management
  • Extension of Therapeutic Indication

Implementation

  • Interim-Management
  • Building and Leading your Nonclinical Department
  • Implementation of Nonclinical Development Plans

Regulatory Writing

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

Nonclinical Development of (Bio-)Pharmaceuticals

  • Study Management
  • Selection of suitable CROs and Vendor Oversight
  • Planing, Placing, Monitoring and Finalization of
    Nonclinical GLP and non-GLP Studies
  • Risk-Benefit-Assessments
  • Justificaton for PDE Values
  • Justification of Relevant Species
  • Gap Analysis
  • Issue Managemet
  • Due Diligences

Nonclinical Safety Assessments

  • Justification of MRSD/FIH
  • Safety Assessments for Excipients, Degradation Products, and Impurities

Nonclinical Development Programs for Medical Devices

  • Elaboration of Biological Evaluation Plans
  • Elaboration of Overall Budget and Timelines
  • Nonclinical Efficacy and Safety Studies
  • Alignment with other Departments
  • Life-Cycle Management
  • Gap Analysis

Medical Devices

  • Chemical Characterization
  • Toxicological Assessments of Extractables and Leachables
  • Combination Products (Medical Device combined with autologous cells)

Nonclinical Study Management of Medical Devices

  • Selection of suitable CROs and Vendor Oversight
  • Planing, Placing, Monitoring and Finalization of Nonclinical GLP and non-GLP Studies
  • Chemical Characterization & Tox Evaluation
  • Safety Assessments for Excipients, Degradation Products, Impurities
  • Issue Management