CHALLENGES WE SOLVE

To be financially successful over the long term, you must deliver compliant products quickly and cost effectively with minimum risk. While many factors can affect your success, few are as important as the quality of your manufacturing operations. These operations depend on several critical factors including the quality of your IT and analytical systems, your scale-up, process control and tech transfer capabilities, how you engage and manage your external manufacturing networks, and how well you manage risk and meet compliance obligations. Focusing on the high value competencies of manufacturing and its related compliance, Skyland Analytics’ helps you accelerate commercialization through market-leading software and services expertise.

Improving Process and Product Understanding

Traditional IT approaches might tell you “what” is happening in manufacturing – but not “why.” Best-of-class manufacturers who leverage their people, processes and technologies get to the “why.” They reduce the number of investigations, decrease cycle times, accelerate tech transfer, increase yields, maintain lean supply chains and achieve better margins. Skyland Analytics’ consultants work with you to create the appropriate organizational strategies and structures, develop your manufacturing master data management, configure the needed data structures and methods, and increase your staff’s effective utilization of statistical methods.

Utilizing Full Capabilities of Informatics

There are a number of IT solutions that meet general data management needs but may not be optimal for your manufacturing operations. You may have gaps in your software portfolio, Manufacturing and Quality IT systems integration challenges, or staff training issues. When you need advice on strategy, architecture, software selection, deployment or training, get support from some of the original developers of BIOVIA Discoverant, a widely used life science manufacturing informatics solution that leverages the value of your paper records and manufacturing data systems. Skyland Analytics helps you deploy and use IT systems (including data analytics software) to elevate production efficiency and satisfy compliance reporting requirements.

Securing Successful Contract Manufacturing Partnerships

The FDA is clear: companies that outsource production must demonstrate “control” over the manufacturing process. Compliance with this requirement is achieved through successful contract manufacturing partnerships. Supply and quality agreements that provide for essential data visibility rights to the product owner and process analytical systems that enable the required process understanding and control, are foundational elements of good partnerships. Skyland Analytics’ life science industry experience spans legal, business development, quality, process engineering and analytics. We are uniquely positioned to help product owners and CMOs identify and implement best practices in their IT, analytics and quality programs, in order to establish compliant, reliable manufacturing networks.

Achieving Right-First-Time Tech Transfer

The transition from process development to full-scale manufacturing – or tech transfer from one manufacturing site to another – is a significant milestone that puts you one step closer to commercialization and revenue. However, process variability and data integrity challenges can slow you down and extend time-to-market. Skyland Analytics has developed proven approaches to process and data issues that enable our clients to expedite tech transfer.

Reducing Product Recalls, Shortages, Failures and Investigations

The quality function in the life science industry has evolved to a proactive one that is increasingly dependent on process and product data analysis. It is no longer sufficient to find and fix problems after they occur. Companies are accountable for understanding and controlling processes—both in their captive production operations and throughout the external manufacturing network. This is especially challenging when production facilities are geographically dispersed and incompatible IT systems impede data sharing and visibility. Skyland Analytics helps you implement best practices in your IT architecture, data management and quality management systems across your manufacturing network.

Complying with FDA Guidelines

The FDA expects life science manufacturers to understand and control their processes. Under the FDA’s Process Validation guidance, manufacturers must submit (on demand) a Continued Process Verification (CPV) plan that provides evidence their production processes are in a state of control. The proposed Quality Metrics guidance advises that manufacturers demonstrate quantitative evidence of their quality process performance. Skyland Analytics helps you meet these regulatory requirements by designing and implementing IT systems including analytics that ensure you are collecting, sharing and analyzing critical data in ways that enable you to continually monitor your processes, respond promptly to FDA requests, reduce frequency and duration of investigations, and minimize the number of inspections.

Meeting SEC Disclosure Requirements

Securities and Exchange Commission (SEC) scrutiny of the life science sector is on the rise. That’s why it’s more important than ever to secure a comprehensive assessment of your risks in manufacturing operations, including intellectual property, control of supply partners, visibility across your external manufacturing network, process IT and analytics, QMS and CPV. Certain risks may require disclosure under SEC Rule 10b-5. With decades of experience in legal, informatics, manufacturing, quality, and process engineering, Skyland Analytics’ consultants can help you identify and remediate material business risks that may require disclosure under SEC regulations and guidelines.

Strengthening M&A Due Diligence

If you are exploring a strategic transaction or investment, speak to us about how we can strengthen your manufacturing due diligence. Skyland Analytics goes beyond the standard cGMP facility audit to comprehensively evaluate overall production processes and performance, IT, analytical and production systems, IP protection, and external manufacturing agreements of your target. Skyland Analytics brings unmatched expertise – in business, IT, data science, quality and legal – to the due diligence process. Our work generates valuable knowledge you will leverage in strategic negotiations, contract and milestone escrows, and integration processes.

In a move to expand capacity, a US-based drug company bought an emerging company in the EU. A cGMP facility audit had been conducted as part of the due diligence process. It wasn’t until after the transaction was complete that the buyer discovered major issues with process control, software validation and analytical capabilities. After inspecting the facility, the FDA issued a 483 letter which prevented any products manufactured at the site to be imported to the US. Remediation was deemed too expensive to pursue, so the recently-acquired plant was closed. Tech transfer out of the shuttered plant was so sufficiently difficult that the transfer was abandoned. The acquiring company still struggles to meet product demand.

An incomplete assessment of the target’s production processes led to:

  • A high-cost, zero-value transaction
  • Unsuccessful technology transfer
  • Product shortages
  • Impairment of market value

Before completing a transaction involving a life science manufacturer, have Skyland Analytics conduct a comprehensive analysis of the production processes, IT systems, production compliance and process capabilities.

BIOVIA Discoverant is a registered trademark of Dassault Systèmes SA