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|Product Range||Regulatory Affairs, Preparing CE Mark, FDA and International Regulatory Submissions,Technical and Design File Reviews, Medical Device Vigilance and Reporting Systems,Risk Management (ISO 14971),Outsourcing Organisation, Quality System Design, Implementation and maintenance to ISO 9001, ISO 13485 and QSR’s (PART 820), Product Classification, Design Control (New Product Development), GMP and FDA Compliance, Validation of Equipment, Processes, Test Methods, Facilities, Product Software, |
Business and Computer Systems validation including compliance to Part 11 And Electronic Records and Signatures, Management Review, Internal and External Auditing, Training – GMP training with an FDA/MHRA focus, Regulatory inspection Gap Analysis, Site/Company Representative for Regulatory Inspections, General QA Support/Advice on how to meet ISO 9001, 13485, FDA and EU GxP Requirements ( Documentation, Change Control, Validation, CAPA/Incident Management)
Supplier Approval and Audit Program Implementation and Management, Pre Audit Preparations (FDA, MHRA, Notified Body), Post Audit Advice and Guidance, Providing a risk based approach to meeting our Quality and Regulatory needs, Process Mapping of your Quality System and related systems, Clinical Trail Advice and Guidance
|Address||116 Almond Road|
|Services||Compliance Solutions has many years of experience within the Life Science Industry (including Blood Establishments) in advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH, for the one man start up to the multi national companies.|
Compliance Solutions supports its clients by providing a risk based approach to meeting their Quality and Regulatory needs with clear, straightforward, hands on practical approach, which is cost effective with regards to assisting with the development, approval, manufacture, storage and distribution of their products.
The consultancy services range from design, implementation and maintenance of Quality Management Systems, preparation of Technical file for regulatory approvals, part-time and interim management support, auditing both internal and external, management reviews and presentations, training and mentoring.
Compliance Solutions understand that your business will often have a varying requirement for consultancy support to meet with the needs of particular projects and activities. That is why we provide you with a flexible approach that is tailored to your exact requirements.
|Phone||+44 (0) 7917134922|