What is pharmaceutical outsourcing or CDMO?
26 March 2018 Le 70e-normandie 0 Comments
Many laboratories today use outsourcing to optimise their pharmaceutical product development. The Contract Development and Manufacturing Organization (CDMO) service adapts perfectly to all the manufacturing stages of pharmaceutical products and devices. But what does this strategy consist of and what are the benefits?
CDMO, a definition
The CDMO is an outsourcing contract established between a pharmaceutical company and a contract manufacturing business. It allows the partial or complete transfer of development and production of a product or a medical device. The contract manufacturers generally have a very wide range of services. The goal is to be able to provide global solutions to pharmaceutical companies, either on an ad hoc basis, or by offering a turnkey service of the product, including galenic and stability developments, marketing authorisation applications, purchases, production and regulatory affairs.
Depending on the company’s needs, contract manufacturers can step in at the early stage of researching a molecule or at the time of packaging before products become available on the market. It is also common to outsource analytical development, conduct of clinical trials and studies on the stability of the medicinal product.
To meet with pharmaceutical industry requirements, contract manufacturers must comply with recommendations from the pharmacovigilance agencies of the host country where the manufacturing site is located. Inspections are most notably carried out by the ANSM in France and the FDA in the United States. In addition, environmental certifications such as ISO 14001 and OHSAS 18001, are criteria that become important in the selection of CDMOs to enter into environmental charters of pharma laboratories.
What is the purpose of pharmaceutical outsourcing?
The CDMO is intended for all areas of the pharmaceutical industry, medicines and medical devices for use in human or veterinary medicine and dermocosmetics. It offers a greater choice in manufacturing processes. This allows pharmaceutical companies to refocus on their business and remain competitive.
The use of pharmaceutical outsourcing makes it possible to benefit from specific skills, equipment and technical resources that the company may not have internally. This has the advantage of limiting project-related investment and thus reducing both costs and risks, In addition, CDMOs takes the time and budget set out by the client into account. Contract manufacturers provide clients with their expertise and are committed to providing quality services that meet current standards.
In conclusion, delegating the manufacture of pharmaceutical products and accessories to a contract manufacturer forms part of a strategic approach. All the CDMOs’ expertise consists of adapting to the needs of pharmaceutical companies in terms of technology, regulation, and development and production capacity.