What we do

CMC Small Molecule & Antibody Drug Conjugate (ADC)

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.

Technical Development

Harmony specializes in offering CMC development solution for early and mid-stage companies. Our subject matter expertise spans drug substance, drug product, and analytical method development. Across our entire organization we proactively employ harmonies principles to support all phases of drug development and commercial manufacturing.

Regulatory CMC

The CMC regulatory landscape is continuously evolving and presents a steady challenge to the development of new small molecules and ADCs. At Harmony we understand this landscape. We are experienced and passionate in supporting our clients to explore, engage and execute CMC regulatory strategies critical for the successful development of new pharmaceutical products.

Quality Compliance

Regulatory compliance, including adherence to cGXP requirements, is necessary to ensure safety and efficacy of pharmaceutical products. It is also key component for successful product development, regulatory approval and maintaining an uninterrupted supply chain.