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

REPHINE REGULATORY PURP PRE SUBM REVIW ICON

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.

REPHINE REGULATORY PURP SUBMISSION SUPPORT ICON

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.

REPHINE REGULATORY PURP POST SUBM LIFECYCLE ICON

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.

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.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

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

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

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

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

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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Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
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