Rephine

GMP Compliance

Rephine supports all types of manufacturers worldwide to achieve compliance to GMP regulations. All GMP projects completed by Rephine are conducted by fully qualified and highly experienced consultants. Rephine's consultants typically have more than 15-20 years' experience within the industry and have been selected through Rephine's rigorous approval process.

The consultants have a broad range of expertise covering different specialties. They are based globally and have expert knowledge on international and local regulations including EU, FDA and TGA.

Consultants are supported by Rephine Head Office's dedicated Account Manager and Production Team that assist in coordinating and managing all projects and audits, making sure that clients receive the highest quality service.

Services include but are not limited to:

• GMP Auditing of all product types (API, Excipients, Finished Products etc.)
• Gap Analysis
• Mock Inspections
• Facility Design Consultation
• Full GMP Compliance Consultation
• Remediation Projects
• Due Diligence Audits
• QP Services

Rephine has a library of GMP audit reports of suppliers that can be provided to customers. Audit reports in the library are comprehensive and satisfy all QPs and regulatory authorities and cover the manufacturing site, meaning that all products are covered by the report. The report allows for customers to receive an immediate independent statement on the GMP compliance of their suppliers and fulfil all necessary regulatory requirements. Visit our updated list of audit reports.

Rephine's Audit Library:

• 200 Audit Reports in Library
• 1000 customers worldwide
• 150 Audits conducted each year
• 100% Customer Satisfaction

Research QA Compliance

Supporting the research and development of medicinal products, Rephine provides a comprehensive portfolio of GxP services, such as:

• Consultancy: CRO/Vendor Selection, Audit Programme Development, QMS Development etc.
• GxP Training and Coaching (GLP, GCP, GCLP, GVP etc.)
• Clinical Research and Clinical Project Management Training
• Facility Audits (Clinical Unit, Laboratory, IMP Depot, Archiving Facility etc.)
• Vendor Audits (CRO, IT Solution Vendor, CTSL Vendor, PV Vendor etc.)
• System Audits (CSV, QMS, Data Management, Records Management etc.)
• Project Audits (BA/BE, Phase I-IV, (e)TMF, Clinical Database etc.)
• BA/BE Study Management and Monitoring
• GxP Inspection Preparation (Audits and Mock Inspections)

Why choose Rephine's consulting services?

Rephine services are provided on a global basis and have achieved a reputation for being of outstanding quality. The natural growth that has been seen in the company supports our aim to be the consultancy of choice for quality matters in the development and manufacture of pharmaceutical products.

Rephine's consultants are a global group of highly qualified experts, with at least 15-20 years' experience in the pharmaceutical/clinical research industry, and at least half of these in auditing and quality assurance.

Did you know that Regulatory Authorities deem remote auditing to be an acceptable solution in exceptional situations where access to a site is not possible? Rephine, with its auditors, API manufacturers, and positive feedback from EU regulatory bodies, has created a remote audit programme that will act as a bridge between current travel restrictions and a future on-site audit.