Pharmaceutical development is creating new drugs and medical devices, from the initial idea to the final product. It is a crucial step in bringing new and innovative treatments to patients. This complex and multi-disciplinary process involves research and development, clinical trials, and regulatory approval.
The process begins in the discovery phase, where researchers identify new drug candidates and develop a basic understanding of their potential therapeutic properties. This phase involves extensive laboratory research, including preclinical testing on cell cultures and animals. Once a promising drug candidate is identified, the next step is to conduct preclinical development, including further animal testing to determine safety and efficacy.
Clinical development is the final step before a new drug can be made available to patients. This phase includes conducting clinical trials on human subjects to evaluate additional safety and efficacy and gather data on dosing, side effects, and other important information. The results of these trials are then used to apply for regulatory approval from the relevant authorities. After the drug is approved, it can be manufactured and distributed to patients. Throughout the entire process, ChRi Labs offers analytical method development and method transfer services to ensure the quality of the drug. Furthermore, ChRi Labs helps companies to navigate the complex regulatory landscape and bring new treatments to market quickly and efficiently.
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: