Services: Nonclinical Development Strategy
Our Nonclinical Safety Development group has significant skills and experience in the design and review of nonclinical development programs over a broad range of therapeutic classes, including small molecular entities, biotechnology derived products, vaccines, and medical devices. We have successfully developed a number of products in multiple therapeutic areas including oncology, hematology, cardiology, neuropharmacology, dermatology, endocrinology, gastroenterology, immunology, infectious diseases, rheumatology, anesthesiology, ophthalmology, nephrology, and pulmunology.
Our work is largely with products in the early stage of development, for which a comprehensive development plan has not yet been created, or during development following the discovery of safety issues. Our experts prepare nonclinical programs that take into consideration the unique properties of the product and optimize the nonclinical program by reducing the number of studies required to support the clinical program while ensuring that the studies conducted adequately meet all the regulatory requirements. Our mission for your nonclinical development program include:
- Optimizing the number, type and timing of toxicology and safety studies to satisfy regulatory agency requirements;
- Design most efficient study designs for your program; and
- Minimize total costs and timelines for regulatory approval.
- Design integrated and streamlined nonclinical safety development plans;
- Provide nonclinical regulatory strategy and supports;
- Provide drug development, toxicology and technical consulting.
- Design, write, compile, and review nonclinical sections for different regulatory submission packages including pre-meeting packages, Investigational New Drug (IND) applications, Canadian Clinical Trial Applications (CTA), End-of-Phase meeting packages, and marketing submissions.
- Act as toxicology experts at corporate and regulatory meetings; and
- Meet and interact with regulatory agencies;
- Write expert safety reports;
- Conduct literature reviews;
- Develop regulatory and experimental strategies for addressing adverse clinical findings;