Regulatory Planning and Execution is vital to every pharmaceutical product, and we have long-term experience and broad resources in negotiating with the Regulatory Agencies. Whether provided as part of overall program management or on a stand alone basis, we advise on the full range of regulatory projects including:

• Filing and Negotiation for Pharmaceuticals, Medical Devices, Combination Therapies
• Target Product Profile, Clinical Development Plan, Risk Management Plan.
• Study Design and Protocol Development
• Orphan product designations
• Regulatory Guidance
• Advice on global regulatory requirements
• Safety Review in Clinical Research and Post-Marketing
• Adverse event report collection & processing
• Adjudication Committee – DSMB establishment & management
• Representation of clients or participation at Regulatory Agency meetings
• Responses to agency questions and appeals