The significance of quality, which refers to the degree of adherence to predetermined specifications for a product or service, cannot be overstated in business relationships. In industries such as pharmaceuticals, where quality defects can endanger patients, it becomes all the more critical. At CPC, we are fully dedicated to ensuring that our products consistently meet the highest quality standards. This commitment to quality is woven into our overall strategy and forms a central mission for every department in our company, guiding our day-to-day activities.
We maintain strict adherence to the Good Manufacturing Practices (GMP) standards. Our compliance with GMP and Good Distribution Practices (GDP) is evidenced by successful inspections by national authorities and audits by satisfied customers. With over 20 years of experience in the industry, we are delighted to provide our customers with end-to-end partnerships in the commercialization of their respective drug substances. This includes support throughout pre-clinical and clinical development, as well as obtaining worldwide marketing authorization.
We collaborate with you to overcome regulatory obstacles and develop the most effective regulatory strategy for your product, not only for commercial purposes but also during clinical development. We compile API dossiers customized to your needs for every life cycle phase, drawing on our expertise.
CPC offers a wide range of API services for peptides and oligonucleotides, including process and analytical development, stability studies, impurity identification, and provision of reference standards. WIth our dedicated team in quality assurance, quality control, and regulatory affairs, we provide support wherever necessary.
We have extensive experience in creating various regulatory dossiers, such as CMC documentation for clinical trial applications, Drug Master Files (DMF), and dossiers for CEP applications.