Services

Technical Consulting

Regulatory, Medical and Quality Consulting for the Pharmaceutical and Healthcare Industry sectors.

Specialised at all stages of the product-life cycle (Research and Development, Clinical Development, Manufacturing, Labelling and Post-Market Maintenance Activities).

Typical activities:

  • Product compliance
  • Collate and evaluate scientific data
  • Author/review registration information e.g. dossier sections and product information
  • Advise on Regulatory requirements
  • Provide strategic advice/direction
  • Review company practises and advise on change to systems
  • Liaise with and present to Regulatory Authorities

Interim and Project Management

  • Project/programme management e.g. to support pharmaceutical registration.
  • Resource management.
  • Business performance improvement.

Business Re-structuring/Change Management

  • Offering help and advice to meet your business needs.
  • Providing specialise skills and expertise to solve your operational problems.
  • Aligning your processes, systems and resource for effective compliance.
  • Providing solutions and transparency to help you to mitigate and manage your Business Risks.

Other Services

Working with our partner organisations, we can provide support in order regulated activities:

  • Pharmaceutical Physician support including Medical Code Approval
  • Pharmacovigilance

We Can Help With

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