Key Elements of a CMC Strategic Development Plan

CMC Regulatory Is the Ringo Starr of Regulatory Affairs
July 31, 2019

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Bad products are rarely the core reason that a biotech company fails. Instead, unsuccessful biotech companies often fail for the same reason that many businesses fail: They don’t have a strong strategic development plan (SDP). When a biotech company has a Chemistry, Manufacturing and Controls (CMC) plan and the program still fails, the problem can typically be traced to failing to adapt to changing business needs and evolving regulations.

  • CMC Regulatory compliance is ensuring that all of the required CMC practices are carried out in agreement with regulatory agencies’ requirements and expectations. Since such requirements and expectations change with time, CMC regulatory compliance helps make certain that all CMC practices are updated accordingly
  • In addition, CMC Regulatory compliance ascertains that if the company has made any CMC specific commitments to the regulatory agencies, either verbally or in writing, that appropriate CMC practices are carried out.

What key elements should every biotech manufacturer and developer consider improving for their success?

Position: Understanding your company’s position and its strengths and weaknesses can increase awareness of issues that undermine the company in some way. With this knowledge, you can plan to overcome from within any obstacles to success and create better overall operating procedures.

Market: Every business needs to understand its market to remain relevant. A plan for obtaining feedback and agreement about the regulatory expectation as it changes can help you connect how your strengths can meet the most important needs.

Goals: You can’t have a strategy if you don’t have short-term and long-term goals. Once you better understand your company’s position and the regulatory expectations, plans based on your goals will serve as guidelines for all future decisions.

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

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

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

Obviously, a strategic development plan should cover every part of the biotech process, including chemistry, manufacturing and regulatory compliance.

The above key elements are the strong foundation on which all the rest is built.