Analytical procedure is developed to test a defined characteristic of the drug substance or drug product against established acceptance criteria. We have extensive/very Good experience in developing robust analytical test methods for the pharmaceutical industry and can provide a well structured, step-wise and focused approach to the analytical method development.
Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose.
Regulatory health authority requires validation for analytical methods. Imprimis performs Analytical Validations for IND, NDA, IMPD, MAA, CTA or aNDA at appropriate level for test methods to include in CMC section.
The stability testing and sample storage options represent extensive, comprehensive programs that provide fully validated and continuously monitored storage environments for all ICH and WHO test conditions. In addition, we provide analytical capabilities to evaluate the physical, chemical, and microbiological properties of solids orals, liquids, semisolids, and parenteral formulations.
Raw material analysis as per pharmacopeia
- Water analysis as per pharmacopeia
- Physico-chemical characterization
- Writing quality report based on QBD
- Writing Validation protocols and performing CSV
- Excipient compatibility studies
- Pre-formulation studies
Imprimis operates in the life science industry often deals with more challenging medical products. Due to drastic technology changes regulations are unable to keep up with the updates, invariably more products tend to reject. Therefore we have bought in teams of specialists who have both scientific skills and regulatory expertise with their ability to communicate and co-ordinate effectively with the regulatory bodies to achieve the very best outcome for our clients.
Cosmetic product will be review based on the guidelines and restrictions provided by respective health authority.
The following product information will be reviewed for the final composition levels as per respective health authority requirement,
Correct INCI name and Composition levels,
Trace impurities and its acceptance level,
Statement of Origin, TSE/BSE certificates,
Prop 65 statement,
Imprimis Pharma Sciences
Welcome to Imprimis Pharma Sciences, one of the best Analytical Laboratory services and Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Imprimis understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Our core areas of works at glance are on Analytical development, Analytical Testing and Regulatory Services of new and existing pharmaceutical products. Imprimis works with any range of company that is looking for quality and in time delivery of services.
WITH GREAT POWER COMES GREAT RESPONSIBILITY