Pharmaceutical Industry - Founders Science Group

Offering A Variety Testing Services

for Pharmaceutical Companies

Welcome to Founders Science Group, your strategic partner in drug product development and testing. Our extensive range of services is tailored to meet the unique needs of pharmaceutical companies, ensuring compliance, efficacy, and safety throughout the Drug product lifecycle.

Why Choose Founders Science Group:

Expert Formulation Services: As the FDA continues to offer guidance to the industry on components that should be eliminated from formulations, FSG can assist in creating and developing replacement and novel formulations incorporating the latest ingredients for enhanced safety, health benefits, and compliance with regulatory standards.
Streamlined Reverse Engineering: Employing a novel and streamlined approach to reverse engineering, we can present viable candidate formulations in significantly less time than is typical, expediting ANDA (Abbreviated New Drug Application) development. Our additional experience in developing 505(b)(2) NDA (New Drug Application) products ensures timely market entry.

Questions? 508-258-8055

Regulatory Compliance and Quality Assurance: We ensure your drug formulations comply with current GMPs and proposed safety and efficacy requirements. Our commitment to meeting the highest quality standards without applying unrelated guidance avoids unnecessary regulatory burdens while ensuring product safety and efficacy.
Advanced Testing Capabilities: Our fully equipped analytical laboratory ensures we can address expected needs, and our R&D experience allows us to work to help solve unexpected challenges during development and commercialization. We specialize in the testing requirements to ensure benzene, residual DEG and EG as well as heavy metals (lead, mercury) are all well within established and expected levels.
Performance, Release and Stability Testing: We all know the burden of routine testing on our industry, equipment needs, routine maintenance and calibrations. Or uneven and lopsided scheduling to meet stability testing needs in addition to meeting the demands for manufacture release. Let our industry trained chemists work with you in confirming these results and eliminate the need for your lab to maintain costly equipment that is infrequently used.

Chemist for Hire: FSG has a program that allows smaller companies or virtual companies to use our chemists on an hourly basis, we call this our FTE (Full Time Equivalent) program, this is a great option for smaller organizations, virtual organizations or anyone who is not completely sure of their needs, appropriate standards or levels to test to or expected results. Our FTE option provides a very cost-effective mechanism to perform dynamic unguided tests and activities.
Packaging and Product Enhancement: We optimize packaging solutions to maintain product stability and quality, minimize degradation, and ensure consumer satisfaction. Our design expertise helps improve patient compliance and results, enhancing product attributes for improved market acceptance and patient experience.
Intellectual Property Development: We assist in identifying and developing IP strategies to protect innovations and differentiate products in the market, providing strategic guidance on patent applications and IP portfolio management for long-term market exclusivity.

At Founders Science Group, we combine scientific expertise, regulatory knowledge, and advanced analytical capabilities to support drug product manufacturers and developers in bringing safe, effective, and innovative products to market. Partner with us to navigate regulatory challenges, optimize product quality, and achieve success in the pharmaceutical industry.

Ready to Take the Next Step?

Drug Formulation Development – we invite you to read our post that dives deeper into successful drug development and CDMOs.

Practical In-House Suite of Teams and Technology for Regulatory and Manufacturing Testing Requirements

From the leadership of our organization to the chemists at the bench, we boast extensive experience in the design, development, and analysis of pharmaceutical, cosmetic, and personal care products. Our team is knowledgeable in the manufacturing of products we develop and can work with your CMO for a seamless transfer.
Utilizing the experienced team at FSG ensures rigorous development of your product and speedy market success.

Leaders in...

Testing

Analysis

Product Development

Storage Solutions

Offering A Variety Testing Services

for Pharmaceutical Companies

Why Choose Founders Science Group:

Practical In-House Suite of Teams and Technology for Regulatory and Manufacturing Testing Requirements

Leaders in...

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