We bring a specific expertise in the following fields:

CNS

Ophthalmology

Oncology

Metabolic diseases

Hormones

Osteoporosis

Virology

Dermatology

Urinary diseases

Antibiotics

Orphan diseases

Vaccines

Diagnostics

Metabolic Diseases

Inflammation and more

Our experts are experienced in the following areas:

Early R&D

Pharmacology

Toxicology

ADME/PK

CMC

Regulatory compliance

QA

Clinical bioanalytics

Clinical support

  

Studies

  • Consultancy on data requirements
  • Organization and monitoring of experimental studies from study design and study plan to study report with strict respect of regulations and rules
  • Study plan and study report reviews

Risk assessment

Dossiers and support

  • Assessment with specific emphasis to
    • Non-clinical Drug Safety
    • Safety strategy implementation
    • Regulatory writing
    • Support to non-clinical safety departments during activity peaks (experimental data assessment, draft report writing…)
    • Problem solving and strategy proposals for exploratory and mechanistic experimentations.
  • Actualization and adaptation to international requirements
  • Preparation for submission with international recommendations
  • Public subventions

Development programmes

  • Strategies
  • Innovation
  • Partnership plans: co-development of new products or new technologies

Primary pharmacology, proof of efficacy and pharmacokinetics

  • Advices to project teams regarding efficacy studies strategy and challenges
  • CRO audit, assessment, selection and monitoring
  • Dose selection
  • Data interpretation and writing

 




Cardiovascular pharmacology and ophthalmology
  • Contribution to laboratory animal ocular adverse effects interpretation
  • Contribution to interpretation of laboratory animal cardiac morphology and function
  • Assessment of relevance for human species and related clinical risk
  • Laboratory animal ocular examination
 
 Toxicology, safety pharmacology
  • Advices to project teams regarding toxicity studies strategy and challenges
  • CRO assessment, selection and monitoring
  • Data interpretation and writing
  • DEREK in silico prediction.
  • Preliminary study implementation and performance. For example MPF selection.
  • Regulatory study design, implementation and monitoring
    Preclinical efficacy and safety assessment.
  • Toxicology, design & interpretation of non-clinical safety aspects of drug development
  • Project & program management
  • Regulatory NCD knowledge and official document writing (IMPD, IND)