How do I move my compound to the next milestone? What types of studies will regulators require? The answers to these questions depend on your compound, its intended purpose, mode of delivery and many other variables. ABC Laboratories will help you answer them with carefully designed programs and studies, reliable data and well-formed applications.
Our Scientific and Regulatory Advisory Team is comprised of industry veterans and PhD-level experts who have authored various sections of numerous Investigational New Drug (IND) Applications, and eight New Drug Applications (NDAs), including two that received first-round approvals from the FDA's Pulmonary Division.
With an average of 18+ years of experience in preclinical development, CMC development, cytotoxic and high-potency compounds, Quality Assurance, Quality Control and regulatory affairs, ABC's consulting team will help you devise strategies that minimize risk and strike that critical balance between regulatory compliance and practical economics.