Development Plan for CMC Strategy

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The main reason that a biotech company fails is rarely because of bad products, unsuccessful biotech companies usually fail for the same reason that many businesses fail: They do not have a strong strategic development plan (SDP).

The problem can typically be traced to failing to adapt to changing business needs and evolving regulations if a biotech company has a Chemistry, Manufacturing and Controls (CMC) plan and the program still fails.

CMC Regulatory compliance is making sure that all of the required CMC practices are performed in agreement with regulatory agencies’ expectations and needs. CMC regulatory compliance helps to make sure that all CMC practices are updated accordingly, since such requirements and expectations change with time.

Furthermore, CMC Regulatory compliance determines that appropriate CMC practices are performed if the company has made any CMC specific commitments to the regulatory agencies, either in writing or verbally.

Some key elements that every biotech manufacturer and developer should consider improving for their success are outlined below:

Market

In order to remain relevant every business must understand its market. A plan for gathering feedback and agreement about the regulatory expectation as it changes can help you connect how your strengths can meet the most crucial requirements.

Position

To increase awareness of issues that undermine the company in some way, it is important to understand your company’s position and its strengths and weaknesses. It is possible to plan to overcome any obstacles to success from within and create better overall operating procedures using this knowledge.

Goals

Without short-term and long-term goals you cannot have a strategy. Plans based on your goals will serve as guidelines for all future decisions once you better understand your company’s position and the regulatory expectations.

Deadlines

Investors expect results that remain within budget and are on-time. The SDP should include special techniques for meeting project deadlines, like hiring temporary technical consultants and other experts to help with management, submission, R&D, and technical writing and/or FDA-related matters.

Resources

The SDP must take critical resources, such as money, investors, technologies (Process and Product Control) and people into account. Your strategy should focus on optimal ways to optimize these resources in a cost-effective and efficient way while still maintaining high standards in every area. You must also plan for future resource needs.

Quality

Good quality control leads to a more streamlined process and a better work atmosphere where all staff and development partners are more motivated to stay with your business and increase their productivity.

A strategic development plan should cover every aspect of the biotech process, including manufacturing, chemistry, and regulatory compliance. The crucial elements discussed in this article are the strong foundation on which all the rest is built.

Acknowledgments

Produced from materials originally authored by Edward A. Narke from Design Space InPharmatics.

About DS InPharmatics LLC

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: Jul 22, 2020 at 5:37 AM

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