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Pharmaceutical Consultancy

Pharmaceutical Consultancy

Rephine is a Pharmaceutical consultancy based in the UK, with offices in India and China. Rephine’s global operation has an enviable record and its knowledge of regulatory requirements is exceptional. Rephine has provided services in most parts of the world and its knowledge of EU requirements is exceptional.

Rephine provides a wide range of clinical and regulatory services for the pharmaceutical, medical device and biotechnology industry, and Rephine Consultants are all highly qualified and very experienced scientists who have worked extensively in the industry.

Rephine assists in meeting challenges in performance improvement, in prodcution, efficiency and cost effectiveness as well as in meeting regulatory requirements, strategic planning and technology transfer.

The Rephine consultancy sevices apply to a wide range of suppliers including API manufacturers, dosage formulators, and excipient manufacturers. Services cover all aspects of manufacture from sourcing, to safety and training. Details of projects undertaken can be provided within the limits of confidentiality.

The Rephine services are underpinned by the highest quality standards, attention to detail and close relationships with clients so that project objectives are met efficiently and cost effectively. The highest ethical and confidentiality standards are maintained at all times.

Rephine also provides GMP audit services on a commissioned basis or through its PharmAssess library of independent audits.

Services provided inlcude:

QP SERVICES

  • PERMANENT & SHORT TERM QP COVER
  • PRODUCT RELEASE
  • QUALITY SYSTEM REVIEW & IMPLEMENTATION
  • RISK MANAGEMENT
  • SUPPLIER ASSESMENT REVIEW & MANAGEMENT

QUALITY MANAGEMENT SYSTEMS

  • QUALITY MANUAL DEVELOPMENT & UPKEEP
  • SITE MASTER FILES
  • TEST METHODS
  • TECHNOLOGY TRANSFER
  • PRODUCT RECALL PROCEDURES

TRAINING

  • SUPPLIER ASSESSMENT PROGRAMMES
  • EU SUPPLIER ASSESSMENT REQUIREMENTS
  • AUDITOR TRAINING
  • RISK MANAGEMENT SYSTEMS & PROCEDURES
  • GMP
  • GDMP

API SOURCING

  • ADVICE ON THE SELECTION OF GMP COMPLIANT API MANUFACTURERS WORLDWIDE
  • ASSISTANCE IN DEVELOPING BUSINESS WITH API MANUFACTURERS WORLDWIDE
  • SUPPLIER EVALUATION

PROJECT MANAGEMENT

  • GMP PROJECT ASSESSMENT
  • GAP ANALYSIS
  • PROJECT DESIGN & IMPLEMENTATION
  • CHANGE MANAGEMENT
  • SCALE UP

AUDITING

  • ICH Q7 API AUDITS
  • FINISHED PRODUCT SITE AUDITS
  • PRE INSPECTION APPROVAL ASSESSMENTS
  • GMP GAP ANALYSIS