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Detailed Services PDF Print E-mail
Working together to accelerate drug development

Overall Regulatory Strategy:
  • Clinical Development planning.
  • Competitor, Disease Area Assessment.
  • Awareness of evolving Global or Regional, National Regulations.
  • Global, Regional e.g. EU Regulatory Strategy considerations etc.
  • Probabiliies of Regulatory success.
Non-Clinical Studies:
  • Competitor, Disease Area Assessment - Intelligence.
  • Non-Clinical Studies (toxicology/ pharmacology) in accordance with Internationally recognised standards.
Clinical Trials (micro-dosing, Phase 0)
  • Design, Applications.

Clinical Trials (Phase I-3):
  • All aspects of EU Clinical Trials, Feasibility, design, Scientific Advice, Applications (EudraCT number obtained), Amendments, potential suspected significant deviations,  serious breaches etc.
  • Ethics committee (EC) Submissions & maintenance.
  • US IND preparation, submission & maintenance.
  • International CTA activities.
  • Internal Audit activities or External Competent Authority GCP Inspections e.g. MHRA (UK).

Clinical Trials (First in Human - Phase 4):
  • Regional (EU) or National (e.g. MHRA, MPA etc.) Scientific Advice (SA) – Clinical Trial Protocol Design.
  • Competitor, Disease Area Assessment – Intelligence.
  • Analysis of current & evolving Global, Regional, National Guidance & Legislation.
  • Regional (EU) or National (e.g. MHRA, MPA etc.) Scientific Advice (SA) – Clinical development Plans.
  • Regional (EU) or National (e.g. MHRA, MPA etc.) Scientific Advice (SA) – Clinical Trial Protocol Design.
  • Paediatric Scientific Advice & Paediatric strategy (PIP, waiver or deferral) .
  • Environmental Risk Assessment (ERA).
  • Description of Pharmacovigilance (PV) Systems.
  • EU Filing strategy (National, MRP, DCP, CAP, Abridged applications).
  • US Filing strategy US (NDA, BLA, SNDA, ANDA).
  • Pre-submission agency meetings (EMEA or National).
  • Risk Management Plans (RMP’s).
  • Regulatory Dossier Assembly.
  • CTD or eCTD Module 1.
  • SPC/ PIL (base, optimistic & pessimistic) draft labelling.
  • Pack Artwork.
  • Braille requirements.
  • PIL User testing.
  • CTD or eCTD Module 2 to 5 (Access to specific Experts for signatures, as required).

‘End Game’ Regulatory Submissions:
  • Dossier submission (translation services, as required).
  • Hands on co-ordination responding to agency questions.
  • Co-ordination of potential Oral Explanation (EMA).
  • Co-ordination of the completion of the respective application procedure (including any post approval commitments).

Approval & Launch:
  • License Approval (product license, wholesale dealer's license, import license).
  • PIL User Testing / Patient Consultation activity.
  • Promotional material review (ABPI code of practice).
  • Innovative Pack design solutions.
  • Routine Artwork amendments.

Post Approval:
  • Life Cycle Maintenance (Variations, Renewals, Line Extensions).
  • Preparation of DSUR’s.
  • PV activities.

Divestment & Discontinuations:
  • Support for compliance, due diligence & handover .
  • Licence Cancellations.

Other: Miscellaneous
  • Freedom of Information (FoI) requests (including redaction strategies).
  • Clinical Monitoring Activities.
  • Support with pre-inspection preparation activities (External Regulator or Internal Quality Functions).
  • Participation during & after inspection (Corrective action & preventative Actions - CAPA).