FOR IMMEDIATE RELEASE: PKG Group LLC & Yonwoo Co Partner with Freyr Solutions Submit DMF File to US FDA
Somerset NJ – PKG Group and partner Yonwoo, leading suppliers of Airless Dispensing System and Primary Packaging Solutions for the beauty, consumer care, and now pharmaceutical markets, in collaboration with Freyr Solutions, a global regulatory consultant agency with over 2,300 technical experts, announce the submission of PKG Groups Drug Master File (DMF) to the US Food and Drug Administration (FDA).
PKG Group is the DMF holder for the dispensing devices and primary packages for semisolid topical and dermatological skin care products that are produced at Yonwoo’s South Korea facilities. The comprehensive technical DMF submitted to FDA provides necessary information about the manufacturing, packaging, and testing of the devices. The DMF filing is an important milestone and positions PKG Group and Yonwoo as key suppliers to pharmaceutical customers launching regulated products in the US FDA market.
“We are pleased to have partnered with a leading global regulatory consulting agency to establish and submit our DMF to the FDA,” said Simon Kassas, Managing Director Healthcare of PKG Group. “This is a significant step forward for our company and we are confident that it will allow our customers to bring innovative solutions in airless dispensing systems to more patients in the United States.”
PKG Group and Yonwoo offer over 400+ stock dispensing devices for topical applications that include airless pumps, jars, tubes, droppers, applicators, child-resistant packages, and many innovative devices like twin chambers, and mix chambers. PKG and Yonwoo are focused on continuous improvement and speed to market innovation processes that help customers develop new devices that meet their patient needs.
“We are committed to providing our customers with the broadest range of innovative and high-quality airless dispensing systems available,” said Simon. “We believe that our products offer the finest metered dose delivery and formulation protection for semisolid topical and dermatological skin care products, and we are confident they will meet the high standards our customers require for their FDA drug formulation and potentially combination product submissions.”
PKG & Yonwoo’s manufacturing facilities are located in South Korea and operate under ISO 15378 standards and cGMP’s for primary packaging of drug product. The companies also have the ability, on certain devices, to meet ISO 13485 standards and CFR 820 regulations related to medical device constituents of a combination product.
In addition to the US based customers, PKG Group is positioned to support global pharma companies working towards FDA approval of topical and dermatological drug product launches. The company is committed to providing its customers with the best possible product, service and support.
About PKG Group
PKG Group www.pkggroup.com is a leading supplier of dispensing systems and primary packaging solutions to the North American beauty, cosmetic, consumer care, healthcare, and now the pharma markets. The company’s products are designed to protect the integrity of topical formulations to help ensure consumer and patient applications. With its headquarters in Los Angeles California, and operations facilities in Somerset New Jersey, PKG Group offers its customers; sales, marketing, design engineering, and all related technical support services to insure customer success and timely product launch.
About Freyr Solutions
Freyr Solutions https://www.freyrsolutions.com is the largest global Regulatory solutions and services company with over 2300+ in house regulatory experts and global presence in over 20+ countries. Freyr offers end-to-end Regulatory solutions to life sciences industries. The services include Regulatory affairs, pharmacovigilance, clinical research, quality management, and technology solutions such as Regulatory information management systems and Regulatory data integration. Freyr’s expertise in Regulatory affairs makes it a trusted partner for life sciences companies seeking to navigate the complex Regulatory landscape.
About Yonwoo Co.
Yonwoo Co. http://www.yonwoo.kr is an innovative trend setter in airless dispensing systems, globally recognized for their speed to market initiatives, packaging innovations, sustainability initiatives, and manufacturing quality products. As one of the most forward-thinking packaging companies in the world, Yonwoo boasts seven manufacturing facilities in Incheon Korea fitted with the latest technologies including an online quality management system (QMS), and automated warehouse. Yonwoo is constantly evolving its manufacturing and quality capabilities to surpass market and customer requirements.
Contact: Simon Kassas, Managing Director Healthcare, skassas@pkggroup.com
