Services Offered:

FDA Meeting Preparation and Engagement

Interactions with the Food and Drug Administration can seem complicated and overwhelming, but there’s no need to go it alone. We assist with planning and preparing for, and even presenting to, the FDA. To ensure your company acquits itself favorably and professionally, and to make your meeting run as smoothly as possible, our FDA-trained consultants are available for the following:

• Represent clients in interactions with FDA
• Assist with preparations for FDA and Advisory meetings
• Provide clients with an “FDA style” review of submissions
• Represent clients in interactions with FDA
• Advise on regulatory options and potential pathways

GMP Training

IOur pharmaceutical scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible services that enable you to achieve a marketplace advantage. Over the last 20 years, our network of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (cGMP) laboratories and regulatory experts have provided high quality technical services ensuring Total Quality Assurance for some of the world’s largest and most innovative pharmaceutical companies.

Pharmaceutical Auditing and Manufacturing Support

Our pharmaceutical auditing and management services give you a transparent view of your supply chain, enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.

Our audit services include:

• Gap assessments
• Pre-Approval Inspection (PAI) readiness
• SOP readiness
• Represent clients in interactions with FDA
• GMP system audit