Rephine performs various GMP audits including Active Pharmaceutical Ingredients (APIs) and Intermediates to ICH Q7 and ICH Q9 standards, as well as excipient, packaging and various other audits. Rephine provides a comprehensive GCP/GCLP consultancy service to ensure that the clinical trials are conducted in compliance with the ICH E6 regulations.
Rephine's portfolio of Regulatory services includes Marketing Authorisations, Product Compliance, Patient Information Leaflets and Regulatory Inspections. Rephine Ltd. is a consultancy that provides a wide range of clinical and regulatory services to the pharmaceutical, medical device and biotechnology industry worldwide.
Rephine's portfolio of Regulatory services includes Marketing Authorisations, Product Compliance, Patient Information Leaflets and Regulatory Inspections. Rephine Ltd. is a consultancy that provides a wide range of clinical and regulatory services to the pharmaceutical, medical device and biotechnology industry worldwide.
Services
Rephine Ltd is a UK based company that offers specialist consultancy services to the primary and secondary pharmaceutical industries worldwide. Founded in 1998, Rephine has become a global market leader and a preferred supplier of third party audits. Rephine supports pharmaceutical manufacturers in producing medicinal products that meet regulatory standards by providing bespoke, cost effective solutions.
Rephine's services are underpinned by superior quality standards, attention to detail and longstanding relationships with our clients. Rephine is dedicated to conducting its work in a transparent manner to ensure that activities are always ethical, and that there is never a conflict of interest. Equally, Rephine understands the importance of confidentiality and treat the information our clients share with complete discretion.
Rephine's activities are accredited to ISO 9001 quality standards and recognised globally. ISO 9001 supports us in building a sustainable business that meets the needs of our customers and provides a consistently efficient level of service. The probability of errors is minimised and projects are completed to exceptionally high standards.
Rephine is continually searching for suitable candidates for our consultancy practice. Positions are available for people with appropriate qualifications and experience, who are either already operating as consultants on an individual basis, or are thinking of consultancy as an alternative career direction.
Rephine frequently performs good manufacturing practice audits at a number of supplier sites around the world to ensure GMP compliance. We carry out Full Site audits which focus on the facility's quality management systems and cover a large number of products. The good manufacturing practice audits are conducted by Rephine's qualified and experienced auditors at no charge to the supplier, every 3 years.
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Corrado Andolina
Oct 17, 2020
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