We have in-house expertise in all of the leading safety and regulatory database operation and management. We host one of the leading solutions in each of these areas for use within our operations for clients and offer our solution as a completely secure, remote access hosted solution for clients.

The Return on Investment offered by us is un- paralleled as we leverage our investment and team across our clients. At a fraction of the cost of implementing your own database, you can have access to the full suite of services that is validated to US FDA 21 CFR Part 11 and EU Regulations.

• Safety Database
• MedDRA Coding Integration
• Signal Detection
• Medical Information & Product Complaint Handling
• Product FAQ, Inquiry Response Management
• Regulatory Database for CTD and eCTD compilation
• eSubmission of Safety Reports & Regulatory Dossier

We are a team of medical and regulatory experts with vast experience in the industry. Talk to us and you will find us knowledgeable and responsive.

Reach out to one of our team members and we will immediately respond to your needs with well thought through solutions. Within North America, please call us at (877) APCER NA and in Europe, call our London office at +44 208 326 3220.