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Freyr Completes 1500+ PDE Reports in Three (3) Years

05-19-2021 09:39 AM CET | Health & Medicine

Press release from: Freyr

Freyr, a leading global Regulatory solutions and services provider, is pleased to announce the feat of completing 1500+ Permissible Daily Exposure (PDE) reports. The feat has been achieved within three (3) years of the implementation of the European Medicines Agency’s (EMA’s) ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/ SWP/169430/2012) across the globe for all the Health Authorities (HAs).

Despite several challenges including the development of PDEs for molecules with very limited or no toxicology/safety data or other considerations like extrapolation to other routes of exposures without sufficient pharmacokinetic information, Freyr developed high-quality PDE/ADE reports/monographs in compliance with the EMA, ISPE, ASTM, and other country-specific guidelines for its 100+ clients across the globe.

Over the years, Freyr’s expert toxicologists have helped many API, excipient, and intermediate including contract manufacturers in their PDE/ADE including Occupational Exposure Limits (OEL) with stringent timelines and on priority as per customer need. In addition, Freyr’s toxicologists have also helped clients by providing responses to Regulatory queries pertaining to PDE/ADE and OEL. Freyr has an in-house team of expert toxicologists certified by the American Board of Toxicology (ABT) and European Registered Toxicologist (ERT) with several years of experience in toxicological risk assessment and regulatory toxicology.

“It gives me immense pleasure that we have been able to help and support 100+ clients across the globe on 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 75% of our customers completely trust us when it comes to PDE/ADE or any other toxicological or non-clinical requirements. Many thanks to them for their belief and trust in our scientific capabilities and services,” added Raghu.

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

Thank you so much Freyr team for helping us on an urgent basis for our ADE requirements for certain Regulatory actives and excipients. Your scientific quality of documents and response time are remarkable. Would love to continue this association for all our future requirements

– A US-based Contract Manufacturing Company

Many thanks to Freyr, specifically toxicologists for helping us on ADE assessment of 80 molecules on priority with high-quality scientific work. Your commitment to the timeline is remarkable.

– A Brazilian major pharmaceutical company

Freyr’s support for ADE/PDE assessment of our products has been tremendous. It has been more than three (3) years that we are dependant and relies on Freyr’s team for our PDE assessments. Freyr’s turnaround time and support during the inspection are appreciated

– UK-based Pharmaceutical Company

Thank you so much Freyr team for helping us on an urgent basis for our ADE requirements for certain Regulatory actives and excipients. Your scientific quality of documents and response time are remarkable. Would love to continue this association for all our future requirements

–A US-based Contract Manufacturing Company

We appreciate the efforts which have been taken by Freyr’s team in submission of PDE reports of requested products at very short notice period. We hope to receive the same support from your end for all future endeavours

– An India-based Healthcare Organization

About Freyr
Freyr is a leading, niche, full-service global Regulatory Solutions, and Services Company supporting, Large, Medium and Small Size Global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) 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 UK, Germany, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Sri Lanka, Australia, Poland, and has Global Delivery Centre in Hyderabad, India.

700+ global clients and growing
950+ global Regulatory experts
850+ regional 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

150 College Road West, Ste 102,
Princeton NJ - 08540

Freyr is a Global Regulatory Solutions and Services company, focusing on the entire Regulatory value-chain ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions to post approval maintenance, Labeling, Artwork Change Management for Pharmaceutical, Generics, Medical Device, biotechnology, Biosimilar, Consumer Healthcare, Cosmetic companies across the globe.

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