Regulatory & Toxicology Solutions provides biotechnology companies with expert guidance and assistance in fulfilling preclinical safety and regulatory requirements for advancing new products into clinical development. We serve as project leaders, respected liaisons to the FDA, and as skillful authors and editors in the preparation of FDA documents. Our expertise includes development and regulatory strategies, scientific design,implementation, and management of your company's programs through all stages of drug development.
To ensure success for your early stage development programs, RTS becomes an integral member of your internal project team to ensure:
The FDA focus is on preclinical safety to assess risk to the patient. We work with your team to characterize potential risks and optimally position these risks for acceptable safety assessments by the regulators.
Our strategic alliances with the top-tier laboratories and certified veterinary pathologists ensure the delivery of timely and high quality product. We will carefully guide your project along using our extensive experience and training.
Knowledge of the regulatory requirements and integration of these milestones into your development program will result in timely production of successful IND submissions.