Advisory Services

With access to the deep intellectual capital of QUMAS employees worldwide, we’ve helped some of the world’s largest pharmaceutical and biotech companies make major strategic decisions surrounding compliance and regulatory issues. Leverage QUMAS expertise to help you implement the business improvements that result in repeatable, sustainable compliance management systems.

 

Regulatory

Regulatory compliance is more than a legal imperative—it’s good business. It can actually be a differentiator for your company, demonstrating credibility to investors and analysts while perhaps helping to distance your business from those that receive negative front-page news coverage. Moreover, solid compliance practices may translate into more efficient, cost-effective and transparent operations—results that are applauded by all stakeholders.

How sure are you that your organization understands—and is appropriately meeting—its many regulatory obligations? How can you be more confident that compliance failures aren’t lurking around the corner?

Our team includes former regulators and professionals with years of industry-specific experience in the life sciences and services field.

 

Submissions

As anyone in the life sciences industry well knows, time is money in the drug development market. Gartner estimates that bringing bringing a drug to market 20 days faster can net an additional $5M in a $100M market; $25M in a $500M market. Adoption of eCTD is forcing life sciences companies to rethink their submissions management strategy. One of the biggest tasks is prepping the documents involved in submissions, especially given the exponential nature of many of the regulatory docs needed. Further complicating matters, an eCTD can have thousands of life cycles, often confusing the regulatory group as to which document to replace and which version is correct. Good life cycle management reduces the risk of product recalls and liability suits - visibility that can avert damage to a company's reputation, brand, and market cap. A successful eCTD must capture all life cycle documents, including responses to questions, variations/amendments, renewals, annual reports, and other materials. We can help you with this critical process in a number of different ways starting with an assessment of your state of readiness. Ultimately the goal is to optimize your chances for success with your submission. Consulting services include:

  • Assisting you with the transition from paper to electronic submissions, which will decrease costs, enhance productivity and minimize quality control issues.
  • Document mapping to submission sections, tracking of submission documents, and timeline and resource management.
  • "Best practices" for document generation, management, and preparation for submissions.
  • In-house needs assessments and process gap analyses.
  • Staff augmentation to complete specific tasks required at key stages in the submission process.
  • Interpretation of ICH guidelines and agency guidance.
  • And finally, development of business processes and the creation of associated standard operating procedures (SOPs) to help your personnel learn to function independently as you increasingly integrate new technologies into your existing environment.

All of these services can expedite your submissions process while increasing the knowledge base throughout your organization. Our regulatory advisors maintain RAC certifications, as well as have extensive experience with global submissions - both paper and electronic-, having worked at some of the largest drug companies in the world optimizing submissions success. While many companies cannot keep up with the rapidly changing submissions guidelines and regulations, our advisors make it their business to maintain ongoing dialogue with the FDA to ensure our clients benefit from the latest interpretations of FDA guidelines and best practices.

 

Custom Workshops

QUMAS Compliance Workshops are designed to help organizations take a fresh look at solving their compliance challenges using proven management and innovative technology strategies.

All of our customers have differing risk profiles, diverse organizational objectives, and a mix of existing compliance solutions in place. With this in mind, we offer a customized, flexible approach that’s based on your specific organizational needs. Our workshops provide you with exceptional value and often yield opportunities to identify and mitigate threats to your business goals. The result can be a more efficient, better-run business.

We also help customers assess the size of their transformation program, provide a guided roadmap, as well as help you document the benefits to senior management, using case studies from other QUMAS clients.

Benefits

  • Tailored "best practices" aligned with your organizational strategy.
  • Product-focused strategy that assures knowledge transfer to your organization in conjunction with your existing IT investments.
  • Optimized business performance and compliance.
  • Minimal effect on day-to-day operations with focused work effort, guided by a detailed roadmap.

What You Will Learn

  • How your organization’s compliance program compares to other organizations in your sector.
  • Identification of gaps in your current program and the steps to remedy them.
  • How your infrastructure will withstand a major incident.
  • How to lay the groundwork for a transformation program, the timetables, tools and next steps.

Who Should Attend

  • Chief Compliance Offers.
  • Chief Risk Officers.
  • Risk Managers and Directors.
  • Information Technology Audit Directors and Managers.
  • Others responsible for implementing, managing risk and compliance.