Offering a broad spectrum of services to pharmaceutical and supplement manufacturers.
Purity, potency and safety. Details that every pharmaceutical and supplement consumer demands. But increased overseas sourcing, along with heightened media and regulatory attention, has made it more difficult for companies to maintain credibility and consistency. That’s why clients turn to STR. Unlike other QA service providers, STR brings over six decades of laboratory experience to every quality assurance test we conduct. We are registered with the FDA as a cGMP-compliant drug establishment, and our regulatory affairs consultants, microbiologists and chemists are global leaders in their fields.
Our gold-standard testing for pharmaceuticals, supplements and their raw materials can be utilized as a stand-alone solution or part of a comprehensive turnkey service.
PHARMACEUTICALS
The best of your client’s life.
The pharmaceutical industry is one of the most heavily regulated industries in our global marketplace—and it should be—our lives, comfort and health depend on the products they produce. If recent pharmaceutical scandals have taught us anything it is that testing has to be task one for the health of the industry.
Our analytical expertise assists companies through the phalanx of testing bodies for both over the counter and controlled prescriptions. We specialize in quality control Pharmacopeia testing, microbial effectiveness, sterility and accelerated/ambient stability testing on the analytic end. Getting better, and staying that way, should be as much about the experience as the outcome. So, our sensory services include the evaluation of flavor, aroma, texture and appearance. And our consumer panels ensure that products perform the way they should when compared against advertising.
Let our expert regulatory affairs consultants, microbiologists and chemists help protect the reputation of your brand from raw material to retail.
NUTRITIONAL SUPPLEMENTS
Providing expertise and leadership to the nutritional supplement industry.
Not all supplements are created equal. As a leading provider of quality assurance services to the nutritional supplement industry, STR helps assure clients that their products meet regulatory and industry standards. We have led the field in developing industry test methods and standards and are uniquely positioned to help clients seeking proven, effective quality assurance programs for their products. We can help assure that your program is in compliance with FDA Good Manufacturing Practices (GMPs); develop a customized program that meets your company’s needs and goals; and help you achieve the highest level of credibility and protection available.
Our services to the nutritional supplements industry includes laboratory testing to ensure compliance to DSHEA, the United States Pharmacopeia (USP) and the FDA GMPs for potency, purity and stability; facility audits for GMP compliance; HACCP programs and audits to help ensure product safety; standard operating procedures (SOP) development and implementation; development of product specifications; claims substantiation; stability studies for expiry dating; method development and validation; and microbiological studies, label review and regulatory consultation.