Controlled Substances Scientific Solutions

Controlled Substance Scientific Solutions LLC is a specialized regulatory consulting firm that provides strategic support to pharmaceutical companies developing drugs with abuse potential. Led by Dr. Michael Klein, the former Director of the FDA's Controlled Substance Staff, the company offers expertise in nonclinical and clinical study design to evaluate abuse liability and dependence. Their services include identifying drug scheduling implications under the Controlled Substances Act and assisting with IND and NDA submissions. The firm helps clients navigate the complex regulatory landscape of the FDA and DEA to ensure successful market entry for CNS-active drug products. By leveraging over 40 years of regulatory experience, the company provides critical insights into abuse-deterrent formulations and risk management strategies.