CATO SMS has the advantage of integrated regulatory, clinical, and scientific expertise. The Consulting and Development Services business unit provides full consulting services to the pharmaceutical, biotechnology, and medical device industries. We specialize in complex development programs requiring innovative regulatory strategies.
Our experienced global team offers services in pharmaceutical and preclinical development through IND (or equivalent), clinical development, and marketing approval including Phase IV post-marketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutraceuticals, medical foods, devices, and diagnostics.
The Consulting and Development Services business unit offers first-line consulting expertise to initiate evaluation and strategy dialogue, offering clients access to design and execution of full product development programs including, but not limited to:
- Product Development Strategy and Planning
- Target Product Profile (TPP)
- Clinical Development Plan
- Regulatory Development Strategy & Submissions
- Clinical Pharmacology
- Nonclinical/Safety Strategies
- Gap Analysis, Critical Risk Identification, and Contingency Planning
Our experts are seasoned professionals who have significant work experience within the medical device, pharmaceutical, and biotechnology industries, collectively participating in the development of more than 50 approved products.