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www.chemicalsknowledgehub.com


Pharma: Outsourcing


and rapid change: leave it to an API procurement specialist. They’ve mastered the high-wire act of preparing, managing, and maintaining their customers’ regulatory submissions throughout the development lifecycle. As the FDA turns more attention to traceability issues and API chain of custody, so too are the most advanced procurement specialists devoting substantial expertise to ensuring the quality and compliance of their clients’ documentation. These specialists are fluent in the opaque language of Active Substance and US-Drug Master Files (ASMF and DMF), Quality Overall Summary (QOS), and Certificates of Suitability (CEP). Are you looking to accelerate a new drug approval under the 505(b)(2) pathway? Or do you need to comprehensively identify and resolve compliance gaps in your existing supply chain? A procurement specialist will consult with you to develop an API source tailored to meet your objectives, whatever they are.


5 You’ll gain the insights and connections you need to plan for the future The most experienced API specialists know the manufacturing industry so well that they’re able to confidently predict future trends and opportunities, helping you to map your individual business objectives to the movements of the global marketplace. It’s not clairvoyance, although it looks that way sometimes. While you focus on innovation, your procurement specialist is focused on the global API market and how to make it work for you. In this way, such a specialist is more partner than vendor. They have access to intelligence databases that keep them in the know about API pricing and importing activities, which helps them negotiate the best prices for you. Some have global offices to give you first-in-line access to facilities in India and China. The best of them attend relevant trade shows and events to continuously strengthen their worldwide network, cultivating flexible supplier relationships that traditional brokers simply can’t offer. These are the relationships that a good procurement specialist can call on when you need customized APIs, or a difficult-to-find molecule, or new chemical entities (NCEs) to meet your drug development needs. Some specialists don’t stop at APIs, either. Need someone who can provide a reliable, pre-qualified fill finish service for your injectables? A good procurement specialist can make that introduction. Need off-site storage


Issue 2 • March/April 2021


to keep you mobilized for rapid growth? Look for a specialist with available warehousing and the logistical solutions to ensure your materials are available on demand.


Towards a more secure supply chain


As an entrepreneur and an innovator, DIY is coded in your DNA. This is one of your strengths, but it also creates pressure to operate beyond the scope of your experience or interests — especially if you’re required to cut costs. Some companies do find an API manufacturer who answers their calls and provides the materials they need. But without a procurement department on-staff, this effort represents a colossal investment of time for front-line employees — time not spent at the lab bench, moving products toward commercialization. Does this represent procurement success? In a way, yes. But it’s a meager success, with a heavy price. It nibbles at that company’s bottom line, limits their velocity, and builds risk into their supply chain. LGM Pharma provides pharmaceutical, biotechnology, and compounding pharmacy clients with expert API sourcing and CDMO services for complete supply chain management across all phases of drug development. With a long-established positive regulatory track record, the company is a trusted advisor for regulatory and market intelligence focusing on quality, customer service and custom solutions to give clients a comprehensive, one-stop solution that reduces risk, increases efficiency, and accelerates a smooth path to commercialization. The company has a history of tailored service for clients large and small, from major pharmaceutical companies to lean biotech startups. If you already have a procurement team, LGM Pharma can extend its reach and strengthen its negotiating power and if you don’t, it can become that team. LGM Pharma can help drive innovation by giving access to the best prices, the greatest flexibility, and the highest quality of API ingredients, right-sized for your project and documented according to the latest regulations and customs requirements.


Further information: LGM Pharma Ph: 1-800-881-8210 E: info@lgmpharma.com W: www.lgmpharma.com


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SPeople – (Photo © iStock / gorodenhoff)


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