Compliance Solutions (Life Sciences) Ltd. has many years of experience within the life science industry (including blood establishments) advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH. We offer tailored support for start-ups to multi-national companies.
Compliance Solutions supports clients by providing a risk-based approach to meet desired quality and regulatory needs. We provide our clients with clear, hands on, cost-effective guidance to assist with the development, approval, manufacture, storage and distribution of their products.
Our consultancy services range from design, implementation and maintenance of quality management systems, preparation of technical files for regulatory approvals, part-time and interim management support, auditing both internal and external, management reviews and presentations, training and mentoring.
Our team of highly experienced consultants mean we can service both the IVD and Medical Device markets with ease and confidence.
Compliance Solutions understand that your business will often have a varying requirement for consultancy support to meet the fluctuating needs of particular projects and activities. That’s why we provide you with a flexible approach that is entirely tailored to your particular requirements.
- Expertise in Medical Devices and IVDs
- Proficiency in Biological, Blood Establishment & Stem Cells industries
- Straightforward and successful regulatory routes to market
- CE, FDA, PMA, Pre IDE, IDE, NICE, MHRA experience
- International regulatory submissions
- A hands-on approach to achieving approvals
- QMS Implementation/Maintenance