Levels of Quality
Our quality team consists of Quality Assurance, Quality Control, and Regulatory Compliance. These departments ensure that our People, Practices, Facilities, Ingredients and Components all meet or exceed the standards mandated by industry regulations and best practices. Our new and a 15,000 sq. ft. science center at our Pennsylvania facility along with the 8,000 sq. ft. science center at our Georgia facility which includes new state-of-the-art formulation development, QC laboratories and a pilot scale manufacturing operation. The Science Center offers a complete range of drug development services, analytical methods development, technology transfers, methods and process validation, ANDA/NDA product submissions, suitability petitions, raw material and finished product and stability testing. Our well trained staff understands the importance of speed, accuracy, and responsiveness. We provide all the resources necessary to take your product from formulation development to commercial production.
Made in the USA & GMP Certified
All USA Pharmaceuticals & Sports Science products are manufactured in the USA under current Good Manufacturing Practices (cGMP) (as defined by 21 CFR part 111) using ingredients sourced from across the world. Our formulators utilize these ingredients in our extensive laboratory facilities to create a variety of popular and unique nutraceutical formulas, ensuring their integrity through rigorous testing.
USA Pharmaceuticals & Sports Science has partnered with independent, third-party auditors such as ASI and PharmaTech Consulting to verify our high production standards and uphold quality in our products. Our staff qualifications, facilities, manufacturing equipment, production processes, and ingredients are routinely inspected by both state and federal regulatory authorities, as well as customer and third-party auditors to assure compliance. Our high standards and accurate execution have earned numerous certifications for compliance as evidence that we can effectively serve our customers.
We manufacture in accordance with stringent international quality standards, so quality assurance is indispensable to our daily work. Every aspect of production is closely scrutinized – from the selection of raw materials through to manufacturing and testing.
We work according to GMP (Good Manufacturing Practices) for medicinal products and HACCP (Hazard Analysis Critical Control Point) for food safety. Our standards are regularly verified through audits conducted by clients and international authorities.
We strive for continuous improvement in order to maintain our quality standards at the highest level. We have a dedicated team of in-house experts that regularly qualify and verify:
We train our staff so that they are up-to-date with latest GMP standards. We track and monitor the training of every individual within the company, ensuring that they are fully equipped for their role and have a personal development plan.
We test all medicinal products, cosmetics, food and dietary supplements according to national and international laws and regulations.
Our quality control regime encompasses every stage of the manufacturing process from inspection of incoming materials, to release and ongoing stability testing of finished products.
To carry out these tasks, our highly qualified staff use state-of-the-art, networked equipment such as HPLCs, GCs, dissolution apparatuses, UV and IR spectrophotometers, autotitrators and other extremely sensitive measuring devices.
Our Drug Regulatory Affairs team helps you to clear all of the hurdles on the journey to regulatory approval. We advise on the most effective regulatory approval strategy for each individual product – be it a medicinal product, food or dietary supplement.
Our regulatory services include
Our regulatory services cover the entire regulatory lifecycle - from initial application to post-approval activities. We can manage registration procedures in the name of the client or register under our own name and transfer the resulting marketing authorizations afterwards.
Our regulatory experts are involved in the research & development phase from the outset, ensuring that the development and registration processes run quickly and cost efficiently so that our clients can get new products to market rapidly.