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