PDE/OEL
PDE Bioexcel
Toxicological Risk Assessment Services
Welcome to PDE Bioexcel
PDE Bioexcel was created by industry leaders with extensive global project experience.
We understand ou rPDE 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.
PDE Bioexcel builds successful collaborations, not just service
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 Maven Regulatory Solutions, we are dedicated to providing premier toxicology and regulatory services that consistently meet or exceed the expectations of our clients and regulatory authorities. Our commitment to quality is embedded in every aspect of our operations, ensuring the safety, efficacy, and compliance of the products we support.
Industries
Pharmaceuticals
Bioexcel expertise to handle the different phases of Drug, Vaccines and Biosimilar registration, from development to dossier Gap Analysis, Preparation and Submission to Lifecycle management.
Cosmetics
Expertise in global regulations like EU directive 1223/2009, US regulations US FDA CFR Title 21 part 700 to 740, Canada Cosmetic regulations, ASEAN Cosmetic Directive (ACD) and GCC GSO standards
Chemical
Bioexcel specialises in CSRA practise in the areas of EU REACH and CLP Registration/Dossier Updates, Hazard Communication (Safety Data Sheet/ Label) Development/ Review/Updates, and Raw Materials Document Management System (RM-DMS).
Veterinary
Bioexcel provides toxicological analyses for food and feed additives. This primarily relates to feed for farmed livestock, but it also includes feed for horses, pets, farmed fish, zoo and circus animals, and wild animals.