Product Safety & Regulatory Support

Pharmaceuticals & Biologics

The development and registration of new pharmaceuticals and biologics is complex, costly, and time-consuming. These products undergo many scientific studies and regulatory reviews prior to entering the global marketplace—often years after the process has begun. Drug safety—which begins with the early preclinical toxicological studies and continues through post-marketing pharmacovigilance—is one of the key factors in determining the success of a new medicine.

ENVIRON’s toxicologists, pharmacologists, and epidemiologists provide product-specific guidance for human drugs and biologics at critical points during discovery, dose selection for safety assessment, chemistry and manufacturing (CMC), efficacy assessment, environmental assessment, regulatory submission, and post-marketing surveillance. Our scientists are fully aware of worldwide regulatory frameworks and emerging scientific issues of concern to regulators. We are uniquely qualified to conduct state-of-the-science assessments needed to support risk-based approaches to product regulation, product development, and product stewardship.

Regulatory approval frequently depends on well-designed and well-executed pre-clinical studies and clinical trials, as well as on submission of a thorough, accurate, and scientifically sound dossier. Our experts can help you prepare the toxicological portions of your dossier to optimize the registration process. Our scientists are highly skilled in analyzing study data, writing scientifically defensible toxicological reports, and representing clients before regulatory authorities.

A recognized pioneer in health risk analysis, ENVIRON is eminently qualified to contribute to the ongoing challenges of ensuring that safe and effective new therapeutics reach the public in a timely fashion.