As the only FDA Regulated, cGMP contract laboratory that is solely dedicated to issues specific to container and package system qualification testing, CS Analytical is home to some of the world’s leading experts when it comes pharma, biotech and medical device packaging. The “All Star” team can help clients define test plans that ensure all regulatory requirements meet or exceed expectations. Offering a plethora of services that cover a wide variety of compendia, CS Analytical is the ideal partner to assist with USP, EP, ASTM and ISO standards that are commonplace in industry. Common and routine test services include:

USP 661.2 & USP 661.2 Plastics              USP 381 Elastomeric Closures

USP 660 Glass Testing                                 EP 3.1.2 Polyolefins

ASTM D4169 Distribution                              USP 1207 Integrity

To support our team of package professional and ensure that all client needs are always met in a timely and efficient manner requires a support team of experienced people dedicated to those quality and business functions that make the entire outsourced testing process simple and streamlined for the client. Our support staff leaders play a key role with client interactions and in many cases work with clients directly to support their testing programs from start to finish.

Sandra Cincotta, Director of Quality

With a quality career specific to contract laboratory testing that spans more than 25 years, Sandra plays a key role in the development, implementation and daily management of the CS Analytical, cGMP, FDA regulated quality system. The CS Analytical quality system is the foundation of the laboratory work we routinely provide to clients. Key functions and client interactions Sandra oversees include:

  • Host & Management of the Client Audit Process
  • Management of the Regulatory Audit Process
  • Management of the Quality Review of Laboratory Data
  • Generation and Final Review of Client Issued Reports
  • Quality Oversight for all Vendor Relationships

Natalie Hoffman, Quality System Associate

Working under the direction of the Quality System Director, Natalie is also a long-term quality professional that has spent more than a decade working in the contract laboratory setting and brings many years of container and package testing experience to the quality team. Key functions that Natalie routinely supervises include:

  • Laboratory Data Review
  • SOP Management & Revision
  • Management of Change Programs
  • CAPA Creation and Implementation
  • Client & Regulatory Audit Support

Linda Freda, Business Operations Manager

A frontline, client facing business professional, Linda is usually the first touch point for many clients. With almost ten years of working in support of container and package testing specialists, Linda brings a wealth of knowledge and experience to each client interaction. She supports the laboratory team via management of many functions that are necessary to keep a cGMP laboratory operating in an effective and efficient manner. Key functions Linda routinely manages include:

  • Management of client service & outreach program
  • Draft and Issue Formal Electronic Work Quotes
  • Client Sample Intake and Sample Management
  • Supply Order and Management
  • Partner Laboratory Relationships

The CS Analytical laboratory team takes great pride in helping clients bring their products through the FDA approval process as they know and understand the regulatory process and challenges that client face.  Behind this team of container and package system experts, CS Analytical has a critical function support team that ensure all aspects of the cGMP quality system and all relevant business and client interaction operations are working in a seamless manner to ensure client goals and objectives are met. Our entire team looks forward to working with you on your testing needs.