Regulatory

As you review and strengthen GMP compliance in worldwide markets, we can help with specific projects such as bringing regulatory filings and submissions up to standard.

Evolving Regulatory Requirements

Our deeply-experienced Regulatory experts can provide help right across the regulatory lifecycle, to ensure that dossiers are up to scratch pre-, during, and post-submission.

From initial dossier review and gap analysis, to hands-on help with eCTD submissions, to longer-term variation management, we’ll help you accelerate market delivery and maintain ongoing compliance.

We can provide these services for both drug substances and for finished drug products.

What Rephine Offers

Pre-submission review

We’ll review your dossier and provide a detailed gap analysis so that you can ensure your submissions are successful first time.

Submission support

Our experts can help you fill any gaps, draft content as needed, and submit the finished dossier to the relevant agencies in the correct eCTD format.

Post-submission lifecycle management

We’ll help you maintain compliance on an ongoing basis, ensuring robust variations management and continuous tracking of evolving authority requirements.

Rephine sets a very high bar for pharma manufacturing supply chain quality assurance. We already know we can rely on our suppliers around the world, but Rephine’s oversight and impeccable reporting gives us the evidence we need to satisfy regulators and ensure patient safety at all times

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

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Case Study

New Solid dosage forms plant

The development of a project for a newpharmaceutical manufacturing plant with ourconsultants will allow you having a plant with anappropriate design to fulfill GMP requirements ...

Company News

Tim Hawkins Joins Rephine as CEO to Spearhead Global Leadership

Rephine, the experts in quality assurance (QA) and Good Manufacturing/Distribution Practice (GxP) compliance across pharmaceutical, biotech & medical device manufacturing supply chains, has announced the ...