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Range of Services PDF Print E-mail
Working together to accelerate drug development
Here below is not an exhaustive list, simply an indication of our recent experience & expertise.

Strategic
  • Clinical development strategic planning & design.
  • Clinical Trials activities, including feasibility, study design, National competent authority (CA) & Ethics Committee (EC) applications.
  • Micro-dosing (phase 0 CTA).
  • Phase 1-4 CTAs.
  • National & European Scientific Advice (SA) Procedures.
  • Voluntary Harmonisation Procedure VHP CTAs.
  • Competitor product assessment.
  • Regulatory Strategy, probabilities of Regulatory success
  • Due diligence, gap analysis activities.

Collaboration & Delivery
  • PIL User Acceptance Testing.
  • Preparation of post-approval change documentation (EU Type 1/2) to an existing market authorization.
  • Preparation of Expert Reports required by CTD Module 2.
  • Assistance in addressing MAA questions & concerns from the Regulatory Authorities.
  • Representation at local Regulatory authorities.
  • Pharmacovigilance (PV) Activities.
  • Risk Mitigation, crisis Management, Regulatory support during pro-active, re-active media communications.
  • Regulatory & Manufacturing consultancy; technical & scientific support.
  • Electronic data management.
  • Audit preparation, internal audit capability & compliance.
  • GMP, GLP, G(a)MP, CFR 21 applications.
 
Education/ Training
  • Bespoke Training & Education Solutions, including Team Building & Leadership skills.