GM Pharma Poised to Secure EU GMP Certification with Support from Huddersfield-based Regulatory Experts
Huddersfield-based Woodley BioReg, a leading regulatory consultancy firm specialising in pharmaceutical, biotechnology, and medical device regulatory affairs, has been appointed by GM Pharma as it progresses towards European Union Good Manufacturing Practice (EU GMP) accreditation. This strategic partnership underscores GM Pharma’s commitment to industry excellence and innovation, positioning the company as a pioneer in the region’s pharmaceutical landscape.
GM Pharma’s decision to pursue EU GMP certification is a significant milestone not only for the company but also for Georgia’s pharmaceutical sector. As the largest drugs manufacturer in the South Caucasus region, GM Pharma is poised to become the first Georgian pharmaceutical manufacturer of drug products to be certified as EU GMP compliant, marking a shift in the nation’s pharmaceutical capabilities.
With a rich history as a former member of the USSR, GM Pharma has emerged as an international pharmaceutical powerhouse, boasting a diverse portfolio of medicines and food supplements. The company holds national and international certificates, permits, and licenses necessary for pharmaceutical manufacturing, reaffirming its commitment to quality and regulatory compliance.
In preparation for its entry into the EU market, GM Pharma is actively undertaking preparatory measures facilitated by Woodley BioReg. These efforts include rigorous compliance with EU GMP standards and the implementation of streamlined regulatory processes to ensure seamless market entry and product approval.
Woodley BioReg founder and principal consultant, Ash Ramzan, said: “Woodley BioReg has a lot of experience in helping manufacturers in the UK, EU, South Asia, China, and South Korea to achieving cGMP certification and then registering their products in highly regulated markets.
“We’re proud of our reputation over the past 25 years and honoured to be selected to help GM Pharma and the Georgian pharmaceutical industry reach the highest standards of quality for human medicinal products.”
The broader impact of EU GMP certification for GM Pharma extends beyond quality and regulatory compliance, offering unparalleled opportunities for market access, streamlined regulatory processes, increased public confidence, and global recognition as a gold standard in pharmaceutical manufacturing. Additionally, this certification enhances Georgia’s reputation in the global pharmaceutical market and stimulates economic growth through increased exports and international trade.
GM Pharma’s CEO Levan Varduashvili also commented: “We are pleased to announce that our pharmaceutical company is initiating the process to obtain EU Good Manufacturing Practice (GMP) certification. Achieving this certification will enforce our commitment to the highest quality standards in the production of our products. It will also serve as a significant milestone allowing us to access the European market, ensuring our international customers can confidently choose our healthcare solutions.”
GM Pharma’s pursuit of EU GMP accreditation symbolises a watershed moment in Georgia’s pharmaceutical evolution, setting a high benchmark for industry standards and paving the way for enhanced competitiveness and excellence across the sector.
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