Compliance solutions highlight regulatory expertise

We have many years of experience in compliance solutions within the life sciences industry to advise on how to best meet the regulatory requirements of the MHRA, FDA, notified bodies and ICH.

Compliance Solutions understands that businesses often have varying needs for consulting support to meet the fluctuating needs of particular projects and activities, and their clients to meet their quality and regulatory requirements at risk- Supports by providing analysis based approach.

We provide guidance to assist our customers in the development, approval, manufacturing, warehousing and distribution of their products, understanding that your business may need to consult frequently to meet the fluctuating needs of special projects and activities. Assistance will be required differently.

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

Diagnostic evaluation, including CEP/CER.

Periodic Security Update Report (PSUR) –

Post Market Performance Follow-up (PMPF) Report

Summary of Safety and Clinical Performance (SSCP)

Performance Appraisal Plan and Reports

Biological Safety Evaluation (ISO 10993) – BER/BEP

toxicology evaluation

Sterilization assessment and support

UKCA and CE marking

MDR Support

IVDR support

· Technical file creation/treatment including supporting documentation.

Analyze differences of technical files or design dossiers

Compliance Solutions is exhibiting on stand A19 at the Med-Tech Innovation Expo. Register for free at www.medtechexpo.com