We strongly believe that sound technical development, regulatory strategy and quality compliance are fundamental building blocks for successful drug development and compliant maintenance for small molecule & ADC products. We understand that it is not practically feasible for early- to mid-stage companies to have all the necessary CMC resources that are required to navigate the web of drug development challenges. Therefore, we have assembled a strong team of CMC professionals with extensive experience in successful development, regulatory filing/approval, commercialization, and life-cycle management of pharmaceutical products.
Harmony is built to function as a seamless extension of your organization, filling your CMC needs with customized CMC solutions to expedite your drug development with maximum flexibility and efficiency without compromising quality and patient safety. We have designed our organization with fully integrated suite of CMC services in the areas of Technical Development, Regulatory Affairs and Quality Compliance. This integrated approach, is available to you with flexible and adaptive models of talent utilization and pricing.
For large, multinational pharmaceutical innovator companies, we provide CMC regulatory services and support that heir requirements in strategic or tactical areas, as needed.