Working with clients to assist in bringing innovative, safe new medicines and medical devices to patients in need.
GET A QUOTESAMPLE TRANSMITTAL FORM‘Our Mission is to work with clients to assist in bringing innovative, safe new medicines and medical devices to patients in need.’
Pine Lake Laboratories is a small GLP/GMP compliant analytical and bioanalytical contract testing laboratory that is FDA registered located in Bristol, CT. Pine Lake Laboratories has extensive experience with method development and validation and specializes in early development work. Pine Lake Laboratories has the capabilities to help pharmaceutical, medical device, and contract manufacturing companies get their product to market faster and more efficiently.
Contract Research Organizations that promote “one stop shop” services with various locations are competitors and are sometimes chosen as the ‘safe option’ due purely on total number of resources. However, choosing a large scale CRO comes with problems of its own; stakeholder ambiguity, increased regulatory scrutiny, and ridged bureaucracy.
Small or midsize projects become less of a priority to companies with the most purchasing power. We give unwavering service across the board, no matter your size or name.
Choosing a smaller contract research organization comes with advantages; flexibility, swift decision making, personalization and communication. There is no barrier between client and President of the company, or large steps from sales to scientist. All employees have a voice and can help the client succeed in getting their product to market safely.
Flexibility
Pine Lake Laboratories understands that the industry is continuously growing and innovating. We strive to be as flexible and adaptive for our clients because we know they are fully immersed. For example, a client may be informed by their vendor of a upcoming material change in the bio-processing system and we will pivot our study plan accordingly for this new material.
Moreover, being a small business, we accept projects that can be seen as a “risk” to large companies; a project that takes a lot of resources due to it being more ‘experimental’ in nature. Pine Lake Laboratories will listen to your companies needs and use our expertise to come up with workable solutions to meet your budget and your teams’ goals.
Pine Lake Laboratories is a dedicated partner in all of the projects we work on and we will remain fully engaged until our customers are satisfied.
Innovation/ Accommodating
The pharmaceutical industry is constantly changing, from new ideas, regulatory guidelines, and best practices. Large CROs could have a hard time adjusting to change, small CROs don’t focus on the high throughput, rinse and repeat strategies. Pine Lake Laboratories will go the extra mile for your product, they have the instrumentation and knowledge to complete your testing and create a data package that can be submitted directly to the FDA.
All customer requests are explored and only accepted if we bring value to a project. Each client is given a personalized study design that will satisfy all their goals for their product. If a service is needed that Pine Lake Laboratories cannot fulfill, we can either outsource or make a referral to an appropriated trusted partner so that our client has piece of mind.
Furthermore, we are able to adapt new study designs quickly and smoothly with our well versed cross-trained experts and all without the unproductive layers of red tape.
Employee Input
Employees from Pine Lake Laboratories come from diverse scientific backgrounds. They bring experience from both small and large pharmaceutical and biotech companies. Pine Lake Laboratories is confident in our abilities to bring the correct technical expert to the discussion table to provide our clients with a full range of GMP and GLP analytical solutions.
All of our employees are dedicated to establishing trust, integrity and delivering results required to build lasting client relationships. Clients can be assured they will not just be another number with Pine Lake Laboratories.
Moreover, Pine Lake Laboratories specializes in services such as CMC Analytical, Extractables and Leachables, Bioanalysis and more. Our equipment required for our service offerings is state of the art. Moreover, our employees are not siloed into just one technique.
All employees participate in the continuous learning program at Pine Lake Laboratories, in order to refresh or educate all employees on leading industry practices. Not one scientist is a specialist on one service or instrument; they are all experts, highly trained on all services and instrumentation.
Personalization
At Pine Lake Laboratories our clients are treated as coworkers. We take time to understand their goals and mission. Their mission statement becomes a part of ours; clients can express their visions, struggles, and outlooks. A call or visit from the President of Pine Lake is only a simple request away and easily accommodated. Dr. Kurt Moyer is happy to visit clients’ offices to meet project teams and fully explain the capabilities and services Pine Lake Laboratories has to offer. Furthermore, visits to Pine Lake Laboratories are also welcome- before or during projects. Clients may want to take a tour of the facilities, meet the team, conduct an audit, or visit during a specific milestone of their testing.
Pine Lake Laboratories makes every step of the process as painless as possible; from quote generation to final report. Again, they can easily speak with our key employees to get any answers to their questions.
Conclusion
Pine Lake Laboratories is a GLP/GMP compliant analytical and bioanalytical contract testing organization that has the capabilities to solve even the most challenging of analytical problems by partnering with our clients, being adaptive, innovative and accommodating, as each client is a valuable member of our team.
Pine Lake Laboratories is fortunate to have Dr. Michael Ruberto as 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:
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.
To learn more about Dr. Ruberto, please visit www.materialneedsconsulting.com
Pine Lake Laboratories is a GLP/GMP compliant analytical and bioanalytical contract testing laboratory. Our lab, located in Bristol, CT, is FDA registered and inspected and DEA licensed for Schedules 1 through V.
