PDE Bioexcel
Toxicological Risk Assessment Services
Welcome to PDE Bioexcel
PDE Bioexcel was created by industry leaders with extensive global project experience.
We understand our PDE clients pulse and strive to exceed expectations at Bioexcel. Our simple but effective approach is quality first, on time. Bioexcel can quickly and precisely supply customised solutions to startups and established manufacturers.
In the fast-paced life sciences field, technology often outpaces regulations. Thus, product approvals can become harder. We created a team of scientific and regulatory experts with technical expertise and strategic regulatory knowledge. Our professionals regularly communicate with worldwide regulatory authorities to streamline submissions and maximise client outcomes.


Welcome to PDE Bioexcel
PDE Bioexcel was created by industry leaders with extensive global project experience.
We understand our PDE clients pulse and strive to exceed expectations at Bioexcel. Our simple but effective approach is quality first, on time. Bioexcel can quickly and precisely supply customised solutions to startups and established manufacturers.
In the fast-paced life sciences field, technology often outpaces regulations. Thus, product approvals can become harder. We created a team of scientific and regulatory experts with technical expertise and strategic regulatory knowledge. Our professionals regularly communicate with worldwide regulatory authorities to streamline submissions and maximise client outcomes.

Our Vision
To be the preeminent leader in toxicology and regulatory services, driving advancements that ensure the safety and compliance of products worldwide. Our vision is to navigate the complex regulatory landscape with unparalleled expertise, fostering innovation and delivering solutions that contribute to a safer, healthier, and more sustainable global environment. As a trusted partner, we aspire to redefine industry standards and empower clients to achieve regulatory excellence.

Our Mission
At Bioexcel, our mission is to protect public health and empower our clients by delivering advanced toxicology and regulatory services. We are committed to thorough, reliable assessments that ensure product safety and regulatory compliance. Through expertise, transparency, and a dedication to excellence, we streamline the approval process, helping clients bring safe, compliant products to market efficiently. We strive to be a trusted partner in advancing public health and regulatory success.

Quality Policy
At Bioexcel, we are committed to delivering exceptional toxicological and regulatory solutions that align with the highest industry standards. Our dedication to quality drives every step of our process — ensuring the safety, compliance, and effectiveness of the medical devices and products we support. We strive to consistently exceed the expectations of both our clients and regulatory authorities.
Toxicology Risk Assessments
Toxicology reports like PDE, OEL, ADE, nitrosamine analysis, Q(s)AR, organic and elemental impurities.
Industries

Pharmaceuticals

Cosmetics

Chemical
