Rephine is a pharmaceutical consultancy that specialises in GMP Audits, including
Active Pharmaceutical Ingredients (APIs) to ICH Q7
and ICH Q9,
pharmaceutical manufacturing consultancy and QP Services and Due Diligence.
Founded in 1998, Rephine is a UK based company that offers consultancy services to the primary and secondary pharmaceutical
industries on a worldwide basis.
Rephine specializes in GMP audits. Our new innovative supplier audit service, PharmAssess™ is revolutionising
the way pharmaceutical manufacturers can meet their supplier audit requirements.
The service improves the level of GMP reporting and provides the
industry with an alternative to repetitive auditing, whilst at the same time reducing costs to the suppliers and their customers.
Our pharmaceutical consultants have many years experience within the pharmaceutical industry and can help to
avoid expensive mistakes before they occur, or are compounded. Rephine can handle projects from conceptual
design through to regulatory approval.
Rephine can also provide QP and consultancy services specifically for IMP manufacturers.
Our pharmaceutical consultants are committed to providing the highest quality service to customers.
Rephine can provide regulatory services to pharmaceutical companies, either as support to internal staff or as a turnkey solution. Rephine’s regulatory
work is worldwide and up to date with international legislation, guidelines and customer practices in all relevant countries.
Regulatory activities undertaken include:
- Submissions to Regulatory Authorisations
- Product Compliance
- Patient Information Leaflet (PIL) Testing
- Undertaking and Managing Regulatory Inspections
For a full list of Rephine’s regulatory services, please visit the regulatory services page. The Rephine regulatory division is based in UK but undertakes activities in most parts of the world.