New Jersey, January 19, 2023: Freyr is pleased to announce the feat of submitting 450 Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports in 2022. The submissions also included the Occupational Exposure Limit (OEL) reports for more than thirty (30) global pharmaceutical companies.

The ADE/PDE values are essential to determine the cleaning limits in the pharmaceutical cleaning validation process as per cGMP requirements. With the recommendation of the health-based exposure limit approach by EMEA and other Regulatory agencies, there is a huge demand for high-quality scientific ADE/PDE assessment reports in the pharma manufacturing world. Similarly, the OEL values help ensure the safety of the workers in pharma manufacturing. Derivation of the ADE/PDE and OEL values requires a very good understanding of pharmacology and toxicology, along with expertise in pharmaceutical risk assessment. Therefore, the EMEA and other Regulatory Agencies recommend scientific credentials and experienced toxicologists to be involved in the drafting and approval of ADE/PDE and OEL reports to ensure high quality and scientific interpretations in the most appropriate manner.

Ensuring the same, in 2022, Freyr’s highly experienced and qualified toxicologists (Diplomate American Board of Toxicology and European Registered Toxicologists) developed and submitted more than 450 ADE/PDE and OEL reports to 30+ customers from various countries like the US, UK, EU, Canada, Australia, Japan, Brazil, South Korea, Egypt, Jordan, Malaysia, Bangladesh, and India. Freyr’s toxicologists have also supported the customers in cleaning validation, including handling GMP audit queries for ADE/PDE assessment.

“We are delighted to announce the successful submission of more than 450 PDE/ADE & OEL reports in 2022,” said Suren Dheenadayalan, CEO of Freyr. “With these consecutive submissions, Freyr has once again proven to be one of the most preferred partners when it comes to risk assessment reports,” Suren added.

Acknowledging Freyr’s expertise in PDE/ADE and OEL services, a few of our clients responded as:

Excellent, thank you all so much! Looking forward to working with you on the next set of reports.

US-based, Leading Generic Pharmaceutical Company

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.

  • 1100+ global customers and growing
  • 1600+ 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
Global HA Mandates
 
x