Pharmaceutical development is a broad phrase used to describe the journey of a new or generic product from conception to FDA approval. The FDA plays an important role in biologics, new and generic drugs. These standards are the highest standards across the globe. For the FDA to approve a new product, the manufacturer needs to demonstrate the product is safe, effective, and high quality.
To ensure these standards are met, the FDA requires proper pharmaceutical testing in FDA laboratories who meet the GMP standards. This includes both the active pharmaceutical ingredients (API) and the finished drug product sold to consumers. To establish bioequivalence, testing using the same standards that are part of the drug approval process for identity, strength, purity, and bioavailability are required.
Since the development of a pharmaceutical drug is complex, the process requires strategic planning and project management. ChRi believes that a consultative approach to pharmaceutical testing helps you best understand the desired pharmaceutical product. We can work together to uncover the chemical profile of the API, drug product/substance, including associated excipients, impurities, and degradants. Our pharmaceutical testing services include:
Our pharmaceutical testing dosage form expertise includes: