New Jersey, January 15, 2024: Freyr is pleased to announce the feat of delivering 300+ Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports in calendar year 2023. The submissions also included standalone Occupational Exposure Limit (OEL) reports and combined PDE/ADE and OEL reports for more than thirty (30) global pharmaceutical companies.
The ADE/PDE values are used in calculation of cleaning limits in the pharmaceutical cleaning validation process. With the recommendation on requirement of PDE/ADE determinations to be based on 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 occupational safety of the workers in pharma manufacturing set up. The determination of ADE/PDE and OEL values requires very good understanding of pharmacology and toxicology, along with expertise in pharmaceutical risk assessment. Therefore, the EMEA and other Regulatory Agencies insists on the scientific credentials and experience of toxicologists involved in the 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) developed and submitted 300+ ADE/PDE and OEL reports to 30+ global customers from various countries like the US, UK, EU, Canada, Australia, Japan, Brazil, South Korea, Egypt, Jordan, Malaysia, Bangladesh, and India. Freyr does not sale or encourage readily available ADE/PDE or OEL reports but always customizes its reports as on current date with latest information and data. In addition, Freyr toxicologists have also supported the customers in their cleaning validation, including handling GMP audit queries related ADE/PDE assessment at no additional cost. With its customer centric approach, Freyr is proudly serving more than 150 customers across the work in their PDE/ADE or OEL and other toxicological risk assessment requirements over several years.
“We are delighted to announce the successful submission of more than 300 PDE/ADE & OEL reports in 2023,” 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 PDE/ADE and OEL services, one of our EU based client responded as:
Thank you Freyr team for supporting us in our high priority requirement and also providing constant support during GMP audit. You guys are exceptional!
EU-based, Leading Generic Pharmaceutical Company
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.
- 1400+ global customers and growing
- 2300+ in-house Regulatory experts
- 950+ 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