New Jersey, September 23, 2021- Freyr, a leading global Regulatory solutions and services provider, is pleased to announce the feat of completing 40+ Permitted Daily Exposure (PDE) reports for a multi-national pharmaceutical company’s Ophthalmic and Otic products.
The development of PDE/ADE for ophthalmic and otic drug products is unique and requires a different approach. Unlike other pharmaceutical compounds there is paucity of nonclinical data including clinical doses and pharmacokinetics. The ADME considerations in the overall assessment play an important role. Therefore, derivation of ADE/PDE values for Ophthalmic or Otic products requires sound knowledge and understanding of the ADME with application of principles of toxicological risk assessment approaches to effectively communicate the appropriate risk.
Freyr developed and delivered high-quality PDE/ADE reports despite several challenges like availability of very limited or no toxicology/safety data, use of read across strategy and other considerations like extrapolation to other routes of exposures without sufficient pharmacokinetic information.
“It gives us immense pleasure that we have been able to support the client on their specific PDE/ADE requirements for Ophthalmic and Otic products 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 preparing PDE/ADE reports or any other toxicological or non-clinical requirements. We are thankful 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 our clients responded as:
We are very happy to acknowledge that Freyr’s toxicologists have helped us in development of high quality PDE monographs for our 40+ Ophthalmic and Otic products. We are very much satisfied with the way Freyr’s team has completed this assignment within short period of time and with highest quality documents. The experience and knowledge of the team is truly remarkable and deserves special appreciation. Would surely love to work with you guys again.
Europe-based Multinational Pharmaceutical Company
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.
Over the years, Freyr’s expert toxicologists have helped many API, excipient, and intermediates, including contract manufacturers in their PDE/ADE requirements including Occupational Exposure Limits (OEL) within stringent timelines. In addition, Freyr’s toxicologists have helped clients by responding to Regulatory queries about PDE/ADE and OEL reports. Freyr has an in-house team of toxicologists certified by the American Board of Toxicology (ABT) and European Registered Toxicologist (ERT) with several years of experience.
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 Center in Hyderabad, India.
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