A key differentiator for CS Analytical is our ability to guide clients on strategies that meet internal and external regulatory requirements for the product in question.
CLIFTON, N.J. (PRWEB) February 03, 2021
CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, has established an Advisory Service line of business to meet the ever-increasing regulatory hurdles our clients face. Unlike the traditional consulting model that simply applies hourly rate for access to key advisors or thought leaders, the CS Analytical Advisory Services model will offer specific advisory packages. They are designed to capture and address common yet specific challenges life science companies continue to face with respect to container/package development and validation. An advisory services package addressing specific topics within a defined scope of service and budget enables clients to get the advice and insight they need without the hassle of open-ended, hourly rate contracts with less a tangible scope and budget.
“A key differentiator for CS Analytical is our ability to guide clients on strategies that meet internal and external regulatory requirements for the product in question. Having operated as an industry consultant prior to CSA, the standard consulting model of charging high hourly fees for answers and guidance that we continually repeat from client to client is not something we are interested in perpetuating”, stated Chief Scientific Officer Brandon Zurawlow. “The a la carte, package-based approach is a logical way for us to add value for our clients, while presenting these services in a defined and budgeted format.”
Although solutions may be custom tailored to a specific company, the regulatory challenges and trends faced by clients tend to be the same across the industry. The traditional consulting model is based upon addressing the same issue for as many clients as possible. Advisory Services will define unique challenges, building a consultative program, price schedule, and set of deliverables for each. Example topics include determination of the Maximum Allowable Leakage Limit (MALL) for a given product, CCI instrument acquisition and method development, method transfer of a CCI method, and defining all relevant USP and EP tests required of a certain package component or system given its intended use. Advisory service packages will be in constant development based on trending challenges and regulatory focus. Advisory services will be offered stand-alone or as part of broader test programs incorporating CSA’s analytical services. Flexibility will be a key component of each package such that each clients’ expectations and needs are clearly defined and addressed through the package scope. Access to industry best practices in a communicable and efficient manner highlights the new approach that the CS Analytical team is committed to taking to meet client demands.
The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.