PERL was founded 2010, our main office is in Ashby-de-la-Zouch, Leicestershire. Over the last 4 years we have been working with both established and developing Pharmaceutical and Biotechnology organisations delivering compliance within Engineering to meet regulatory requirements. We maintain a close working relationship with our clients to ensure their engineering needs are fulfilled in a timely manner, delivering projects and routine services, meeting the highest quality standards.
We have had our projects and services successfully reviewed and audited, within clients facilities, by both FDA and MHRA regulatory inspections. We have also represented our clients as Area Experts during regulatory audits to assist licence approvals.
We enjoy a high level of repeat business and continue to develop a strong reputation within the industry for the integrity of our work.
PERL personnel are trained to work to both GMP and GDP best practice within client’s facilities.
Our company focus on continuous improvement and delivering the highest quality services and products to meet all regulatory requirements.
We are also committed to ensure that our own internal processes and documentation follow best practice and will meet current industry requirements.
PERL personnel have over 20 years experience within regulatory and compliance facilities and have extensive knowledge of the following guidelines:
- US FDA: Title 21 CFR Part 11
- ISPE GAMP ‘Maintenance’
- ISPE GAMP ‘Calibration Management’
- UK MHRA: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 – the ‘Orange Guide’
- ISO Standards