15 Minutes

The merger will enable Rephine and the TDV group to provide a one-stop-shop for more of their clients’ needs, and materially expands the live GMP audit report library to 750+.

 

Stevenage, Hertfordshire, July 06, 2022 – Rephine, a firm of deeply experienced GMP auditors specialising in pharmaceutical supply-chain quality assurance, has announced its merger with Barcelona-based GxP audit organisation Forum Auditorias and its technology and manufacturing supply chain compliance consultancy TDV. The combined organisation creates the clear market leader in its field, with an audit report library of over 750 valid GMP reports spanning more than 2,500 products; around 100 full-time employees; and coverage of 100+ countries, encompassing all major manufacturing locations.

Forum Auditorias is a leading third-party GMP auditing organisation, formed nearly two decades ago and known worldwide for the quality of its service. Combined with Rephine’s already impressive library of live GMP (good manufacturing practice) and GDP (good distribution practice) audit reports, the merger brings the total size of the audit report library to more than 750 reports, spanning thousands of individual pharma product lines.

TDV specialises in GxP consulting, with deep expertise in all aspects of manufacturing, especially around IT systems validation and implementation. It is also a preferred partner in Europe for the leading Quality Management System software platform, TrackWise Digital from Sparta Systems, part of Honeywell Inc. The combined organisation plans to expand its TrackWise services into additional markets.

“By combining the two best organisations in this sector, we are creating the clear market leader in our niche – in terms of the scope of services we offer clients, our international reach across manufacturing supply chains, and in the number of valid, high-quality reports available for clients to purchase from our audit report library, which will be the largest in the industry,” said Adam Sherlock, CEO of the combined group. “This will make a big difference to clients, who want to be able to manage an increasingly complex supply chain without having to manage numerous different suppliers.”

Commenting on the merger, Octavi Colomina, CEO and founder at TDV, said, “We are delighted to be able to share a very bright future together with Rephine. The synergy between our organisations is very strong. We share the same reputation for quality, our cultures are highly compatible, and our strategic visions are tightly aligned. Our respective clients will feel the benefits greatly, both through a streamlined, simplified engagement and via access to a bigger library and more extensive resources. Put simply, our combined service along with our digital platform capability will take the friction out of supply chain management.”

The consolidated organisation will operate from three primary locations – Stevenage in the UK, Barcelona in Spain, and Shanghai in China. The senior executives from both the Spanish business and the Shanghai location will join the extended Rephine group leadership team. Following the merger, Octavi from TDV will step back into an advisory role. The Rephine Group will continue to look for additional strategic opportunities to further expand its global presence and services offering.

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About Rephine

Rephine is a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance. As well as conducting audits on an as-needed basis, Rephine offers the single largest repository of live reports (within three-year validity), spanning thousands of individual products. More at www.rephine.com

Rephine is backed by Kester Capital, a leading UK-based private equity investor focused on Healthcare & Life Sciences, Information & Data, and Technology businesses that require capital to unlock their potential. More at www.kestercapital.com

Press contact for Rephine

Carina Birt, Sarum PR, 07970 006624, [email protected]

 

About AFA

Forum Auditorias (AFA) is a leading third-party GMP auditing organisation, formed in 2005 to be a reference platform for the pharmaceutical industry to qualify the entire pharma supply chain by means of GxP audits according to the most up-to-date GxP interpretation. It is accredited according ISO 17020, which ensures the quality, confidentiality and absence of conflict of interest.

More information at: www.forumauditorias.org

Press contact for AFA

Laura Mallo, +934178065 [email protected]

 

About TDV

TDV is a leading consulting firm focused on providing technical and quality solutions to the Pharmaceutical, Medical devices and Biotech industries for global GxP (GMP, GLP and GCP) compliance.

Since 1997, the company has been supporting companies worldwide in the life sciences field, assisting in the preparation of FDA and EMA inspections, providing IT system validation services, process validation consultancy, GMP compliance audits, commissioning and qualification, TrackWise quality management systems implementation as well as training services. More info www.tdvct.com

Press contact for TDV

Elena Peña, +34934178065, [email protected]