Rephine

About Rephine

Rephine is a pharmaceutical consultancy that specialises in GMP Audits, including Active Pharmaceutical Ingredients (APIs) to ICH Q7 and ICH Q9, and excipients, 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.

GMP Audits

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.

Pharmaceutical Consultancy

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.

Regulatory Services

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.