Ensuring Product Safety, Efficacy & Compliance
We at Foursquare Pharma Labs are committed to providing the best possible pharmaceutical quality control and testing procedures in the pursuit of improved health by turning your concepts into solutions. Our entire endeavor has been motivated by the desire to improve human life quality and our goal is to impact millions of people around the world everyday. This state-of-the-art facility features innovative technology, ultramodern equipment and scientifically mandated technologies. Its team of dedicated scientists is well-versed in performing analytical testing of pharmaceuticals, drugs, impurities and biological products in accordance with GLP practices.
At Foursquare Pharma Labs, our vision is to become a globally recognized center of excellence in pharmaceutical quality control and testing services. We are committed to supporting the life sciences industry with integrity, innovation, and precision—ensuring every medicine meets the highest standards of safety, efficacy, and compliance.
We aim to build long-term partnerships with our clients by delivering reliable data, fast turnaround times, and regulatory-ready documentation that supports product development, release, and market approval.
At Foursquare Pharma Labs, we provide a comprehensive suite of pharmaceutical quality control services tailored to meet global regulatory requirements (ICH, FDA, EMA, MHRA). Our laboratory is equipped with cutting-edge instrumentation and staffed by experienced analysts and microbiologists. Below are our core service areas:
We design and develop robust, reproducible, and stability-indicating analytical methods for new and existing pharmaceutical products. Our team evaluates key parameters such as selectivity, sensitivity, and system suitability to ensure methods are fit-for-purpose and transferable across labs or global sites.
All developed or compendial methods undergo ICH Q2(R1) validation. This includes accuracy, precision (repeatability and intermediate precision), linearity, range, specificity, detection and quantitation limits, and robustness testing, fully documented with a validation protocol and report.
Verification ensures that compendial methods (e.g., from USP/EP/BP) perform effectively on the client's product. We confirm suitability for use through limited testing focused on specificity, precision, and system suitability, as required by regulatory guidelines.
Testing of active pharmaceutical ingredients (APIs), excipients, and packaging components as per pharmacopeial and client-specific specifications. Our capabilities include identity, purity, potency, and microbial limit testing, ensuring material compliance before manufacturing.
We perform long-term, accelerated, intermediate, and forced degradation studies in ICH-compliant chambers (25째C/60% RH, 30째C/65% RH, 40째C/75% RH). Our reports support regulatory filings and include photostability, packaging compatibility, and stability-indicating assay development.
Using ICP-MS, we detect and quantify trace-level elemental impurities (Class 1, 2A, 2B, 3) in accordance with ICH Q3D. This testing supports risk assessment and ensures compliance with PDE (permitted daily exposure) limits for human safety.
Our lab evaluates potential chemical compounds that may migrate from containers, closures, or medical devices into drug products. Testing includes simulation, extraction, and analytical profiling using LC-MS/MS, GC-MS, and ICP-MS to assess risk and ensure regulatory compliance.
We offer microbiological assays such as bioburden, endotoxin (LAL), sterility, microbial limit testing, and preservative efficacy. Our lab operates under aseptic and cleanroom conditions and follows EU GMP Annex 1 for environmental monitoring and contamination control.
Integrity testing, moisture vapor transmission, seal strength, and compatibility studies for primary and secondary packaging materials. Ensures physical and chemical compatibility with drug products and regulatory compliance (e.g., USP <661>, <671>).
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