Compliance Solutions highlights regulatory expertise

Compliance Solutions has many years of experience within the life science industry advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH.

Compliance Solutions understands that businesses will often have varying requirements for consultancy support to meet the fluctuating needs of particular projects and activities, and supports its clients by providing a risk-analysis based approach to meeting their quality and regulatory needs.

We provide our clients with guidance to assist with the development, approval, manufacture, storage and distribution of their products, understanding that your business will often have a varying requirement for consultancy support to meet the fluctuating needs of particular projects and activities. 

End-to-End support from development through quality management systems, regulatory submissions and clinical trials, with services including, but not limited to:

· Clinical Evaluation, including CEP/CER.

· Periodic Safety Update Reports (PSUR)-

· Post Market Performance Follow-Up (PMPF)Report

· Summary of Safety and Clinical  Performance (SSCP)

· Performance Evaluation Plan and Reports

· Biological Safety Evaluation (ISO 10993) -  BER/BEP

· Toxicological Evaluation

· Sterilization assessment and support

· UKCA & CE Marking

· MDR Support

· IVDR Support

· Technical File Creation/Remediation, including supporting Documentation.

· Perform gap analysis of Technical File or Design Dossiers

Compliance Solutions is exhibiting on Stand A19 at Med-Tech Innovation Expo. Register for FREE at www.medtechexpo.com