OUR MANUFACTURING RISK ASSESSMENT

Get an objective evaluation of internal and external production operations with an assessment that includes GxP, product and process performance, IT systems, IP protection, CMO contract terms and other risk factors. We’ll identify your strengths and vulnerabilities and deliver custom recommendations for optimizing efficiency and mitigating risk.

Industry Risks

If you manufacture pharmaceuticals or devices, there are several risks that may impair your business and/or jeopardize your compliance. You’re already monitoring many of them, but here are a few that may require more scrutiny.

  • FDA Guidelines for CPV
  • SEC Scrutiny into manufacturing operations
  • Data Integrity
  • Supply and Quality Agreements
  • M&A

Work With Us To Protect and Optimize Your Business

When manufacturing risks go unaddressed, the consequences can be serious: product recalls and shortages, failed tech transfer, higher COGS, FDA or SEC violations, loss of market value and more. You’ll be in a stronger position to manage these risks if you’ve conducted a thorough Manufacturing Risk Assessment Skyland-MRA.

Why Skyland Analytics?

Our Skyland-MRA is unique for a few reasons:

  • Industry Experience: We have experience in manufacturing drug products and devices and understand your unique challenges.
  • Holistic Perspective: Our team views your situation from multiple points of view-applying manufacturing, data science, quality, IT, legal and business expertise.
  • Analytical Capabilities: We understand the role of IT and analytics in manufacturing and quality management.
  • Flexibility: We tailor the MRA to your needs. For example, if a cGMP audit has been done recently, we might focus on data integrity, IT and analytical systems.
  • Action-oriented: We will give you an action plan to mitigate any risks uncovered in the analysis.

Risks are on the rise in the life science manufacturing sector. Some are quite obvious; others may be flying under your radar. As a leader of, or advisor to, a life science manufacturer, you may be held accountable for identifying, managing and disclosing risk. Invest in a Skyland-MRA from Skyland Analytics to limit your liabilities, uncover opportunities and put your business on a path to profitable growth.

Schedule your consultation today