At Bioexcel, we deliver detailed Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) reports, supported by a team of highly qualified toxicology professionals, including European Registered Toxicologists (ERT) and Diplomates of the American Board of Toxicology (DABT). Our expertise ensures that your pharmaceutical operations meet the highest global safety and compliance standards.
Why Trust Bioexcel for PDE and OEL Reports?
Our ERT- and DABT-certified experts bring unparalleled knowledge and global experience to every project. With their deep understanding of toxicology and regulatory requirements, we deliver precise, reliable, and regulatory-compliant reports to safeguard your products and personnel.
Key Benefits of Choosing Bioexcel:
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Accurate Assessments for Multi-Product Facilities
Our toxicology experts evaluate all relevant data to calculate PDE values, ensuring compliance with EMA and ICH Q3C/Q3D guidelines.
Key Features:
Protecting Your Workforce with Expert Guidance
Our OEL reports define safe exposure limits for pharmaceutical compounds, reducing occupational risks in manufacturing environments.
Key Features:
Mitigate Risks with Advanced Toxicological Expertise
Our ERT and DABT-certified experts identify and address risks associated with manufacturing and handling pharmaceutical compounds.
Key Features:
Ensure Safety and Compliance Across Products
We help you prevent cross-contamination and ensure safe operations in multi-product facilities by integrating PDE and OEL data into your cleaning validation and manufacturing processes.
Key Features:
Seamless Regulatory Submissions with Expert Reports
Our reports meet the stringent requirements of EMA, FDA, OSHA, and other regulatory authorities, ensuring smooth submissions and audits.
Key Features:
Certified Professionals
Our team includes ERT and DABT-certified toxicologists, recognized globally for their expertise.
Unmatched Accuracy
Advanced methodologies and scientific precision in every report.
Regulatory Excellence
Deep knowledge of global standards ensures compliance with EMA, FDA, ICH, and OSHA.
Comprehensive Solution
Tailored services for multi-product facilities, high-potency APIs, and complex regulatory requirements.
Our certified ERT and DABT experts ensure the highest level of accuracy, compliance, and reliability, providing a competitive edge for our clients.
Yes PDE reports are required for multi-product facilities under EMA guidelines, while OEL reports are critical for safeguarding worker health in line with OSHA standards.
Absolutely! Our PDE reports are integral to cleaning validation processes, ensuring compliance with EMA and ICH guidelines.
With Bioexcel’s team of ERT and DABT-certified toxicologists, you gain access to world-class expertise for your pharmaceutical safety and compliance needs. Let us help you prepare precise, regulatory-compliant PDE and OEL reports that protect your patients, workforce, and operations.
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