We provide expertise in Quality Control Testing, Method Development, Validation, comparative dissolution and Stability Storage facility and Testing of pharmaceutical raw materials and finished products at state of the art GMP complaint facility. Prime Health is providing independent, contract analytical services to the global pharmaceutical and related industries.
Our modern facilities and state-of-the-art equipment allow reliable, reproducible analysis, whether you need routine Quality Control Analysis, method development, generic product development or water testing, Prime Health has the expertise and resources to serve your needs.
Pharmaceutical equivalence studies (Comparative dissolution profile) is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. At Prime Health comparison of therapeutic performances of two medicinal products containing the same active substance will help assessing the possibility of alternative using between the innovator and any essentially similar medicinal product.
Prime Health raw material testing will help provide purity, contamination, Residual Solvents and material testing services, for a variety of raw materials. Raw material quality control is necessary to prevent product failure and ensure a consistent level of quality, as well as safety in consumer and industrial products.
Stability testing (Using stability indicating methods) at Prime Health Lab will help to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability Storage is structured as multiple chambers, which are designed to meet various temperature conditions, required by FDA and ICH, as well as other conditions required specifically by the client. All of storage chambers are continuously monitored by a computerized system, with temperature and humidity set-point windows at ±2° C and ±5°RH.
Finished product testing will be performed as per guidelines by FDA. All finished products must be tested prior to distribution. The tests that are performed will ensure that the product meets established specifications and that these specifications account for its purity, integrity, efficacy, and concentration. The tests can include titrations, Spectrophotometer, pH, conductivity, HPLC, GC, AA, and others.
Prime Health aims to focus on following core strengths to provide excellence in product testing:
An independent Quality Assurance unit comprising of trained & experienced professionals with analytical, quality assurance and regulatory compliance expertise will be committed to Prime Health’s Quality Management System (QMS) & Accreditations