Outsourcing regulatory activities

When your focus is on growing your international business, you don’t want to be limited due to a lack of skilled resources in your QA/RA team. Is your team struggling to meet expected registration process timelines? Do you face issues with your document management? Many of our clients have a challenge to find sufficient, experienced, regulatory talent.

Let us help you with our one-stop regulatory solution whereby we offer following services:

• Regulatory submissions and lifecycle management

• Global regulatory strategy and intelligence

• Medical device artwork management

• Dossier & clinical evaluation report preparations

• Regulatory staffing

• PMS (Post Market Surveillance) follow-up

We provide cost-efficient staffing resources supporting manufacturers like yourself in several QA/RA activities. Some examples of the activities we support with are:

1. GSPR (General Product Safety Regulation) creation

2. Review and updating IFU’s

3. Gap Analysis of the Harmonised standards

4. SOP creation including Risk management, Vigilance, CER, PMS etc.

5. Preparation of different country specific technical dossiers

6. Label updates including implant card creation

7. Research and checking latest data regarding PMS published online

8. Creating and updating the CERs

Our partner has developed several, AI supported modules. From basic support through to full-time regulatory support. 

Our AI compliance bots give you all the information you need and support you in your QARA activities. 

Our part-time regulatory support solution is focused on start-ups and SMEs that need project basis support or a virtual regulatory department. It provides basic document review preparation, assistance for regulatory submissions, PMS and vigilance support and compliance updates and alerts. 

Our full-time regulatory support option is the ideal solution for companies requiring ongoing regulatory compliance and submission support. This includes, besides the services offered in the part-time regulatory support solution, detailed regulatory documentation, complete regulatory submissions and comprehensive PMS.

Our solution:

• Is provided by experienced professionals to manufacturers from over 30 countries;

• Provides efficient documentation, timely decision-making, and support across different time zones to minimize disruptions and costs through an AI-backed medical device registration specialist;

• Is cost-effective through our experienced partner, specialist in compliance for Medical Devices and IVD and well equipped to handle global projects.