We feature a state of the art laboratory with dedicated scientists that will deliver efficient and innovative solutions for even the most challenging projects. We have extensive experience in developing and validating methods for multiple applications, specialize in early development work and have a proven record of FDA compliance.
In addition to being FDA GMP compliant, Pine Lake Laboratories is DEA licensed to receive, store and analyze drug products containing schedule I-V controlled substances. We have extensive experience working with a broad range of drug product formulations containing controlled substances. We have performed E&L studies on container closure systems and transdermal delivery systems for controlled substances as well as CMC analytical testing support.
We launched our Connecticut laboratory in the early 2000s and have had a loyal staff and satisfied customers since. For nearly 20 years Pine Lake Laboratories has been innovating to provide the best services to our customers, creating trusting and professional relationships that best serve the patients in need.
Dr. Moyer is currently the President of Pine Lake Laboratories and was the General Manager of Pine Lake Laboratories predecessor NSF Health Sciences for over 10 years. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University.
Kevin has been with the laboratory for 10 years. Kevin serves as the business and finance manager, supports sales and marketing, and oversees operations including IT support. Kevin has a B.B.A. in Business Management from Western Michigan University.
Ulyana has been with the laboratory for over 11 years. She manages multiple study types and is an expert in bioanalysis, extractables and leachables, and analytical testing of combination medical devices. Ulyana has also responsible for introducing new technologies and the installation of our laboratory information management system. Ulyana earned an M.S. in Chemistry from Kazan State University in Russia.
Cassandra has been with the laboratory for over 10 years. She manages multiple study types and is an expert in extractables and leachables, analytical testing of combination medical devices and CMC analytical testing. Cassandra is also responsible for maintaining our training program and our DEA controlled substances. Cassandra earned a B.S. in Chemistry for Western New England College.
Richard Wedlich is currently Director of Quality Assurance for Pine Lake Laboratories and held the same position with Pine Lake Laboratories’ predecessor, NSF Health Sciences, for over 10 years. Prior to that, Mr. Wedlich served as Executive Vice President of Pharmalytica Services (Newington, CT) for nearly 10 years. He was Senior Research Engineer in the Chemical Development Department at the Schering-Plough Research Institute (Union, NJ), Senior Research Chemist for Olin Chemicals Research (Cheshire, CT) and Senior Scientist for Lockheed Engineering, Management and Sciences Company (NASA Johnson Space Center, NM). Mr. Wedlich holds an MS degree in Chemistry from Marquette University and BS in Chemistry from Ramapo College of New Jersey.”
Dr. Michael Ruberto is a retained consult available to support all extractable and leachable studies.
Dr. Ruberto is the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management. He has been an active member of various pharmaceutical working groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms. Some of these teams include:
PQRI Orally Inhaled and Nasal Drug Product E&L Working Group PQRI Parenteral and Ophthalmic Drug Product E&L Working Group United States Pharmacopeia (USP) Packaging and Storage Expert Committee Dr. Ruberto was formerly the Head of Regulatory Services for the NAFTA region at Ciba Specialty Chemicals where he was responsible for worldwide notifications of new products, food contact notifications, and regulatory compliance of Ciba chemicals. At Ciba Dr. Ruberto also served as the Director of Analytical Research. Dr. Ruberto was employed by Ciba for fifteen years.
Dr. Ruberto received a B.S. with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from Seton Hall University