Small Molecule Therapeutics

Well-planned regulatory strategies–including Chemistry/Manufacturing Controls (CMC), pharmacological, and toxicological studies–are critical for drug development programs. PharmaNet/i3 pharmaceutical and regulatory consulting experts include former senior-level officials with both the FDA Center for Drug Evaluation and Research (CDER) and international agencies. These professionals understand the unique issues related to small molecules drugs and can assist you with regulatory strategy, CMC preparation, clinical trial design issues, and other technical considerations to gain marketing approval for your products.