BOULDER, CO: January 12, 2016. Robert M. Di Scipio, Esq., CEO of Skyland Analytics, says the firm now offers a targeted set of risk management services for Life Science manufacturers. According to Di Scipio, risk is on the rise in the Life Science sector, due to trends such as greater manufacturing complexity, explosive growth in contract manufacturing and increased scrutiny into manufacturing operations by the Food and Drug Administration (FDA) and the Securities and Exchange Commission (SEC). Skyland Analytics' risk management services align with these trends.
"It's been our experience that many Life Science manufacturers focus on FDA compliance, but are not fully aware of the increased attention the SEC is paying to their space," says Di Scipio. "The SEC seeks to insure that companies disclose material business risks to investors. Increased complexity in Life Science manufacturing is driving additional risks related to process control, product quality, data visibility, data ownership, intellectual property protection and more. We help clients identify, score and mitigate these risks."
Skyland Analytics' Manufacturing Risk Assessment (MRA) is conducted by a team of professionals with Life Science manufacturing, quality, IT and data science expertise, as well as legal and business experience in regulated industries.
"Our key people are some of the original developers of Discoverant®, a widely-used informatics solution for Life Science manufacturers," says Di Scipio. "We deployed it successfully with more than 20 of the world's top drug and device manufacturers—in both captive and contract manufacturing organizations. We've seen first-hand the business and legal risks that can result from outsourcing. These risks can be mitigated with properly structured agreements and informatics systems that ensure process data visibility for the drug owner."
The Skyland Analytics MRA includes an in-depth analysis of GxP, product and process performance, IT systems, IP strategy and protection, contracts with external partners and other risk factors. Using data from multiple corporate, manufacturing and quality systems, the Skyland team determines if, where and why risk exists. Findings and recommendations are presented in a risk scorecard.
"The goal is making it easier for clients to understand where their strengths and vulnerabilities lie, so they're better positioned to mitigate risk and optimize operations," says Di Scipio.
In addition to the MRA, Skyland Analytics offers consulting services including Manufacturing Informatics Software Selection, Configuration and Training; Contract Manufacturing Search and Selection; Design of Supply and Quality Agreements; Manufacturing Intellectual Property Strategy and Protection; and GMP Audits.
For more information about Skyland Analytics, visit skylandanalytics.net or contact Marty Zuzulo ([email protected], 877.607.4445 x702).
* Discoverant is a trademark ® of Dassault Systemes SA.