New Jersey, Sep 25, 2023 – Freyr Solutions, the largest global Regulatory solutions and services provider, is delighted to announce its strategic partnership with PKG Group LLC. The collaboration led to a successful submission of PKG Group's Type III Drug Master File (DMF) to the US Food and Drug Administration (US FDA).

For the Type III DMF registration support, Freyr has delivered a wide range of services, including meticulous gap analysis of the documents, compilation of the dossier in eCTD format, and expert guidance throughout the submission process. Freyr has also extended support for managing queries from the US FDA and ensuring a smooth and efficient submission process.

Ravi Kankanala, Senior Director, Freyr Solutions, added, "Freyr has always been dedicated to providing our customers with the highest level of Regulatory submissions’ support. Our partnership with the PKG Group exemplifies our commitment to excellence and ability to navigate complex Regulatory procedures and streamline submission activities in a quick TAT. We congratulate PKG Group on this milestone submission and look forward to continuing our journey together."

Simon Kassas, Managing Director - Healthcare of PKG Group, expressed his satisfaction with the partnership, stating, "We are pleased to have partnered with Freyr Solutions, a leading global Regulatory consulting agency, to establish and submit our DMF to the US FDA. 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."

About PKG Group

PKG Group 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 ensure customer success and timely product launch.

About Yonwoo Co.

Yonwoo Co. is an innovative trendsetter 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 an automated warehouse. Yonwoo is constantly evolving its manufacturing and quality capabilities to surpass market and customer requirements.  

About Freyr

Freyr Solutions is the largest global Regulatory solutions and services company that 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.

  • 12+ years in the life sciences Regulatory landscape.
  • 1350+ global customers and growing.
  • 2300+ in-house Regulatory experts.
  • A Global presence across 20+ countries.
  • 850+ in-country Regulatory affiliates across 120+ countries.
  • ISO 9001 & ISO 27001 Certified.
  • ISO 27001 Certified for information security management, state-of-the-art infrastructure.