Freyr Submits 400+ HBEL (PDE/ADE & OEL) Reports in 2024

"Freyr is pleased to announce the feat of delivering 400+ Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports in the calendar year 2024. The submissions also included standalone Occupational Exposure Limit (OEL) reports and combined PDE/ADE and OEL reports for more than twenty-five (25) global pharmaceutical companies.

The ADE/PDE values are used in the calculation of cleaning limits in the pharmaceutical cleaning validation process. With the recommendation on the requirement of PDE/ADE determinations to be based on a health-based approach by EMEA and other Regulatory agencies, there is high demand for good quality ADE/PDE assessment reports in the pharma manufacturing world. Similarly, OEL values help ensure the occupational safety of the workers in the pharma manufacturing setup. The determination of ADE/PDE and OEL values requires a great understanding of pharmacology and toxicology, along with expertise in pharmaceutical risk assessment. Therefore, Regulatory agencies insist on the scientific credentials and experience of toxicologists involved in drafting and approval of ADE/PDE and OEL reports.

Freyr's highly experienced and qualified toxicologists (Diplomate American Board of Toxicology and European Registered Toxicologists) have developed and submitted 400+ ADE/PDE and OEL reports for 25+ global customers from various countries like the US, UK, EU, Australia, Japan, South Korea, Egypt, Indonesia, Malaysia, Bangladesh, and India. Freyr does not sell or encourage readily available ADE/PDE or OEL reports but always customizes its ADE/PDE or OEL reports with the latest data/information as of current. In addition, Freyr toxicologists have also supported the customers in their cleaning validation, including handling audit queries related to ADE/PDE assessment at no additional cost. With its customer-centric approach, Freyr has been proudly serving more than 150 pharmaceutical companies across the world in their ADE/PDE or OEL and other toxicological risk assessment requirements for several years. Freyr has a 20+ highly qualified and experienced team of nonclinical experts and toxicologists dedicated to supporting Regulatory toxicology and nonclinical writing activities.

"We are delighted to announce the successful submission of more than 400+ PDE/ADE & OEL reports in 2024," said Satyanarayana Krishnamurthy, Senior Vice President and Head of Medicinal Products Division at Freyr. "With these consecutive submissions, Freyr has once again proved as one of the most preferred partners when it comes to risk assessment reports," Satyanarayana added.

Acknowledging Freyr's expertise in ADE/PDE and OEL services, one of our US-based generic pharmaceutical clients responded, "Awesome, great work Freyr toxicology team. Thanks for all your help and support in delivering high-quality PDE reports within a short time".

About Freyr
Freyr is one of the largest, global, Regulatory-focused solutions and services companies for the Life Sciences industry. We support large, medium, and small size global life sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain, ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc., to Post-approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions. Freyr is also expanding its footprint into other key areas like Pharmacovigilance.

Headquartered in New Jersey, USA, Freyr has regional offices across the UK, Germany, France, Switzerland, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Sri Lanka, Australia, Poland, China, Japan, and a Global Delivery Center in Hyderabad, India.

1650+ global customers and growing
2100+ in-house Regulatory experts
850+ in-country Regulatory affiliates across 120+ countries
ISO 9001 Certified for strong process and quality management
ISO 27001 Certified for information security management, state-of-the-art infrastructure"

Link: https://www.freyrsolutions.com/press-releases/freyr-submits-400-hbel-pdeade-oel-reports-in-2024

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Princeton NJ - 08540, USA"

Freyr is a Global Regulatory Solutions and Services company, focusing on the entire Regulatory value-chain ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions.

This release was published on openPR.