Regulatory Science Ltd, Largs Yacht Haven, Irvine Road, Largs, KA30 8EZ

Pharmaceuticals

Pharmaceuticals


With a collective experience of decades in the pharmaceutical industry, RSA’s Associates can provide all the advice you need to accelerate the progress of new drug candidates through development and on to the market, together with maintenance of registered products.

RSA can provide a tailored service for the client; from consultation on a specific technical issue to managing a programme of activities to support product registration and life cycle management.

Services

Technical Services
  • General toxicology
  • Inhalation toxicology
  • Genetic toxicology
  • Mechanistic toxicology
  • Repro. & Dev. Toxicology
  • Neurotoxicology
  • Regulatory toxicology
  • Regulatory pharmaco-toxicology
  • Carcinogenicity
  • Dermal absorption
  • Metabolism and kinetics
  • QSAR Evaluation
  • Pathology
  • Environmental Risk Assessment for US(FDA) and EU(EMA) submissions
Regulatory Affairs
  • Pre-clinical Strategy
  • Project Management
  • Advocacy
Dossier Preparation
  • Data gap analysis
  • Risk Assessment
  • Study summaries
Study Management
  • Study Design
  • Study Monitoring
  • CRO liaison

Our expertise also covers environmental risk assessment, including understanding the potential relevance of mode of action and ‘read-across’ from pre-clinical data to environmental species.

Blog

ECETOC/RSA Thyroid Satellite Symposium Flash Report
Navigating Endocrine Disruption Assessment Under EU Legislation
Unveiling the indirect liver enzyme mediated thyroid effects of Valifenalate on rats and dogs which is not relevant to humans