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).
- 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.
Working with our partner organisations, we can provide support in order regulated activities:
- Pharmaceutical Physician support including Medical Code Approval