The Role of CMO’s in Life Sciences Manufacturing

by | Nov 9, 2021 | Analytics, Compliance, Consulting Group, Data, FDA, Guidance, ISO, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


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Navigating ever-changing markets and supply chains has been challenging for many companies in the ongoing pandemic world. Many manufacturers are pivoting their business models for cost optimization and thus shifting to an increased reliance on contracting services. A contract manufacturer is a company an organization hires to handle all the manufacturing services. Working with a contract manufacturer helps companies with limited resources to have the ability to create great products.

Cost optimization is a significant reason why companies choose to outsource. Additionally, as the pharma industries transition to more complex biopharmaceuticals and personalized medical devices and therapies, there’s a more considerable manufacturing capacity demand. The global competitive environment has led to the streamlining of manufacturing R&D, medical writing, clinical data management, and other processes1.

Greater manufacturing capacity demands also drive increased complexity in supply chain operations, making them significantly more challenging to manage. Many of the new therapies and small molecule pharmaceuticals require smaller batches and more intricate technological components2. A new level of supply chain collaboration is needed to have supply chain management and be profitable properly. Manufacturers collect abundant amounts of data over the product life cycle to ensure the products meet the intended specifications. CMO’s can improve communication, collaboration, and control over the outcomes.

Supply chains are the underpinning of business operations. Companies working with contract manufacturers need fast and straightforward answers. The global supply chain may never go back to the way it was, forcing businesses to adapt to supply chain changes if they want to reduce uncertainty3. Dealing with a contract manufacturer means the CMO primarily deals with the raw material suppliers, leaving the CMO to deal with overseas suppliers.

Contract Manufacturers can complicate supplier management systems.  EMMA International has experts to adapt your quality, regulatory, and compliance systems and help ensure the contract manufacturer meets all your needs.  EMMA International does it all. EMMA International can help innovation reach reality; give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.

  1. Life Sciences BPO market (service type: Contract manufacturing organizations [active pharmaceutical ingredients {API}, final dosage form, and packaging], contract research organizations [drug discovery, preclinical trials, clinical trials {I, II, III, IV}, medical writing, pharmacovigilance, clinical data management, Regulatory Services, clinical monitoring, biostatistics, protocol development, and Site Management], contract sales organizations, and others) – global industry analysis, size, share, growth, trends, and forecast, 2019 – 2027. Transparency Market Research. (n.d.). Retrieved November 8, 2021, from https://www.transparencymarketresearch.com/life-sciences-bpo-market.html.
  2. Disruptive Outsourcing Means Life Sciences Are Relying on CMOs More Than Ever. (n.d.). MasterControl. Retrieved November 8, 2021, from https://www.mastercontrol.com/gxp-lifeline/disruptive-outsourcing-means-life-sciences-are-relying-on-cmos-more-than-ever/
  3. Taichman, A. (n.d.). Council Post: Improving Operational Efficiency With Contract Manufacturing. Forbes. Retrieved November 8, 2021, from https://www.forbes.com/sites/forbestechcouncil/2021/08/02/improving-operational-efficiency-with-contract-manufacturing/?sh=2292ac0b10d3

Alexis Ferrier

Alexis Ferrier

Alexis is a Quality Engineer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

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