Freyr Records 300+ PDE and ADE Report Submissions in 2021

2024-12-26 01:56:32 Computer

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Freyr, one of the largest, global, Regulatory-focused solutions and services companies for the Life Sciences industry is pleased to announce the development of 300+ Permitted Daily Exposure (PDE) and Acceptable Daily Exposure (ADE) reports in the calendar year 2021, for more than 35 global pharmaceutical companies.

The ADE/PDE values are essential to determining the cleaning limits in the pharmaceutical cleaning validation process as per the cGMP requirements. With the recommendation of a health-based exposure limit approach by the EMEA and other Regulatory Agencies, there is a huge demand for high-quality scientific ADE/PDE assessment reports in the pharma manufacturing world. Over the years, with a team of highly experienced and qualified toxicologists (Diplomate American Board of Toxicology and European Registered Toxicologists), Freyr has supported numerous small, medium, and large pharmaceutical manufacturers across the globe for their ADE/PDE requirements. The Freyr team has developed ADE/PDE reports for more than 1500 molecules. The ADE/PDE database at Freyr includes all types of formulations (oral, topical, parenteral, ophthalmic, otic, etc.) and therapeutic categories (CNS, CVS, metabolic diseases, steroids, hormones, vitamins/minerals, including highly active/hazardous drugs) of pharmaceutical products and other inactive ingredients (excipients, intermediates, and cleaning agents).

In 2021, Freyr?s toxicology team developed and submitted more than 300+ ADE/PDE reports to 35+ customers from various countries like the US, the UK, the EU, Australia, Japan, South Africa, Malaysia, Thailand, Indonesia, Sri Lanka, Bangladesh, and India. Freyr?s toxicologists have also supported customers in their cleaning validation, including handling GMP audit queries pertaining to ADE/PDE assessment.

?It gives me immense pleasure that we have been able to help and support customers across the globe for their PDE/ADE requirements with the highest quality scientific evaluations,? said Raghu Setty, General Manager ? MPR Medical Writing Services at Freyr. ?And it is remarkable that all our customers completely trust us when it comes to PDE/ADE or any other toxicological or non-clinical requirements. We truly appreciate their belief and trust in our scientific capabilities and services,? added Raghu.

About Freyr
Freyr is one of the largest, global, Regulatory-focused solutions and services companies for the Life Sciences industry supporting, 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.

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, and has a Global Delivery Center in Hyderabad, India.

950+ global customers and growing
1200+ in-house Regulatory experts
900+ 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