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Pharmaceutical companies of all sizes rely on contract service providers for vital services. Managing operations and establishing an effective working relationship are key factors in avoiding compliance problems.
FREMONT, CA: A pharmaceutical company can be an established, large, well-established pharmaceutical or biotech company with extensive supply chains or a virtual company focusing on research and development while outsourcing its development, manufacturing, and fulfillment functions. CMOs play a vital role in manufacturing pharmaceutical products for some pharmaceutical companies, while they play a much smaller role for others. Any company can benefit from outsourcing if it complies with a few key factors.
The key challenge in addressing these factors is fostering a quality culture that promotes communications and collaborations internally and throughout the supply chain.
Suitable CMO: In the selection process for CDMO and CMO, life science companies must consider more factors than price, more than any other industry. An intense regulatory environment, capability, capacity, availability, and the overwhelming need for a "right-first-time" process all ensure a potentially life-saving drug is developed, manufactured, and distributed properly.
Managing CMO: A strategy for managing CMO is important for life sciences companies of all shapes and sizes, not just startups with limited resources that rely solely on CMO. A comprehensive oversight strategy is also essential for large pharmaceutical and biotech companies that utilize CMO for specialized manufacturing of a limited-run or specialty drug or for manufacturing a product that requires specialized expertise or equipment.
Communication and collaboration: Managing a global virtual organization requires excellent communication and collaboration between CMO from around the world. Pharmaceutical companies should not view the supply chain as a strictly unilateral mandate and operate exclusively for their benefit in a modern strategic approach. In this zero-sum model, pharmaceutical companies try to gain the most benefit for themselves at the expense of contract manufacturers. A modern and effective approach focuses on sourcing and managing CMO as a win-win relationship rooted in collaboration, considering all stakeholders' interests. With this approach, your company will get a strategic partner that shares its values, not just a vendor concerned with transactional activities.
CMO and contracting organizations need to avoid data silos to achieve effective communication. By improving supply chain efficiency and enhancing sourcing decisions, the free flow of data will simplify regulatory oversight and oversight. A company's CMO manager will facilitate this free exchange of information between the company and its CMO, as well as between departments within the company.