Life science manufacturing faces growing operational risks and greater scrutiny from the FDA and SEC.
Are you at risk?
Answer these 6 questions to make a preliminary assessment of business and legal risks in your manufacturing operations.
- Are you aware of SEC Rule 10b-5 and how it impacts your manufacturing business?
- Will your CPV program satisfy an FDA audit?
- Have you optimized your tech transfer capabilities by leveraging manufacturing and quality data?
- Are you certain that your strategic due diligence efforts go deep enough into manufacturing process capabilities and data management?
- Have you or your external manufacturers been free of product recalls, shortages, failures and / or investigations in the last 18 months?
- Are you certain that your external manufacturing contracts preserve your manufacturing IP, provide for real-time data visibility and preclude your manufacturing partner from competing after patent expiry?
If you answered “no” to any of these questions, you may be vulnerable to business and legal risks in your manufacturing operations. Let Skyland Analytics help you better understand these risks and how you can mitigate them.
