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.
Our team of highly experienced consultants mean we can service both the IVD and Medical Device markets with ease and confidence.
Compliance Solutions (Life Sciences) also have a network of specialists who are brought in on a project by project basis to give expert support. Learn more about the core team here.
Edwin is a Micro/Molecular Biologist with extensive experience of working in the Life Sciences and Medical Devices/IVD Industry for over 20 years and has proven expertise in regulatory affairs, clinical, quality and validation.
He has recently been a member of the UK Trade and Investment Healthcare Advisory Group consulting the UK government on healthcare issues and export.
Angela is a Bioscientist/ Microbiologist with extensive experience of working in the Life Sciences and Medical Devices Industry for over 20 years with proven expertise in regulatory affairs, quality and validation.
Angela also has extensive experience working with regulatory agencies e.g. Notified Bodies, MHRA, US FDA, Health Canada, Japanese PMDA. Angela has extensive experience with the validation and routine processing for several modes of sterilization as well as the supporting of sterility assurance program activities covering sterilization, microbiology and sterile barrier systems.
Jon is a Mechanical Engineer and has worked in the Medical Devices and In Vitro Diagnostics Industry for over 25 years and has proven expertise in regulatory affairs, quality and validation.
Jon also has extensive experience working with regulatory agencies e.g. MHRA, Health Canada Notified Bodies, US FDA and has encompassed roles at Smiths Medical, Stanmore Implants, Owlstone Medical. He has worked with all classes of device from active to implantable, including custom devices.
Tara is a Biologist with extensive experience of working in the Medical Devices and In Vitro Diagnostics Industry for over 10 years and has proven expertise in regulatory affairs, quality.
Tara is an experienced clinical project manager and trained clinical monitor, allowing her to successfully drive clinical strategies for clients, liaising and submitting to competent authorities and hosting regulators for multi-site clinical trials, as well as communication dialogues with ethics committees and all aspects of reporting requirements to ensure smooth regulatory clearance post-trial at the point of the submission process.