Since 2002, Affygility Solutions has been providing high-quality permitted daily exposure (PDE)1 reports (a.k.a. monographs) for active pharmaceutical ingredients. These PDE reports have been sold to over 800 clients in nearly 70 countries. These reports are authored by Diplomate American Board of Toxicology (DABT) and European Registered Toxicologists (ERT) as recommended by the following regulatory authorities:
In April 2012, Affygility Solutions was the first company in the world to offer the online, instant download of OEL and PDE reports. As of June 2021, the CPhI award-winning OEL Fastrac catalog currently has over 1,900 PDE reports. Customers have rated our PDE reports and support at a Net Promoter Score of 100!
OEL Fastrac ADE / PDE reports offer the following benefits:
As defined by the EMA’s Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, “The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.”
The PDE is then used in performing your facility’s risk assessment, according to ICH Q9, and used in the maximum allowable carryover (MACO) equation.
Each PDE report contains the following information:
At Affygility Solutions we see hundreds of different PDE reports each year. Often, when reviewing reports from cheap providers, we see many technical errors and tactics to fool you into thinking that you’re getting quality reports. These technical errors and tactics include:
Other toxicology providers sell cookie cutter monographs that are prepared by inexperienced and uncertified teams. In contrast, Affygility Solutions follows a quality-focused process when preparing PDE reports to ensure we deliver comprehensive and compliant monographs. With an increasing number of complex regulations in the pharmaceutical industry, Affygility Solutions’ experienced team of toxicologists routinely reviews new regulatory requirements and guidance to determine regulatory impacts. You can always count on Affygility Solutions to be at the forefront of developing regulatory requirements and trends.
Customers can be certain they’re receiving thorough and complete reports because Affygility Solutions has a 34-step quality assurance process to validate accuracy of all monographs. Affygility Solutions also uses proprietary software tools to be altered when new safety information becomes available that might impact the OEL or PDE calculations.
Affygility Solutions has a long history of providing and supporting toxicology services. This proven track record gives customers peace of mind they’re receiving quality monographs backed with exceptional support.
Affygility Solutions also prepares PDE reports for natural health products to address the growing nutraceutical and herbal medicinal markets. As the natural health product industry continues its upward trajectory, the need for increased toxicology expertise and resources is also rising. With Affygility Solutions’ knowledge of the complex regulations in the pharmaceutical industry, we are able to help our customers understand the unique toxicology requirements in the natural health product market. Natural doesn’t always equal safe.
To order online by credit card simply go to our OEL Fastrac online catalog. To request a quote for your PDE reports, simply go to our contact us form.
Affygility Solutions has been providing occupational health, safety, and toxicology services since 2002. Affygility serves biotechnology, pharmaceutical and medical device companies throughout the world. We provide health based exposure limit (HBEL) monographs, occupational exposure limits and acceptable daily exposure limits for active pharmaceutical ingredients available for instant download through OEL Fastrac. Our other services include the Affytrac EHS management tool, potent compound safety and categorization, and genotoxic impurity evaluations. Affygility’s international team is located in the United States, Canada, Brazil, and the United Arab Emirates.
We can help support your international programs anywhere in the world. Contact us to find out more.