Simson pharma, a renowned name in pharmaceutical sector, has build its high reputation as a complete solution provider in contract research arena. We are leading manufacturer and supplier of pharmaceutical reference materials like drug working standard, drug impurity standards, drug metabolites and stable isotope labelled compounds.
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Our expertise in this area has made us one of the the most trusted companies in the industry. We are the front runner in manufacturing complicated drug impurity standards or reference materials and the complete solution provider in identifying, synthesizing and qualifying any unknown impurity.
we have scaled up our operations to make the company a holistic solution provider and would be supplying all reference chemicals and materials for research requirements .
In short, we are one stop solutions for chemical development, formulation development, analytical development and regulatory services.
we have variety of services to cater to different needs of pharma sector. Our primary services include:
with our state of the art research laboratory, we handle a range of scientific formulation development and support it with analytical testing, too. We deliver end-to-end solutions irrespective of the complexities involved in the delivery. Primarily the formulations we develop include tablets, capsules, liquids, parental and powder for oral suspension.
at our laboratories we have all the cutting edge instruments for analytical testing. We provide testing services like method development, method validation and onsite laboratory operation and in consequence giving boost to formulation development.
we provide a broad range of regulatory and compliance expertise with comprehensive project management to ensure that each development project meets us fda, mhra, emea and other global regulatory standards including qbd expectations.
Research solution in custom synthesis:
we at simson pharma have the research and development ability for synthesis of some of the most complex molecules. We also provide services of complete literature searches to ensure that most efficient synthetic route has been created and standardized.
at simson pharma, all our products are synthesized under glp guidelines. Our laboratory has been inspected by leading pharmaceutical quality assurance teams and few regulatory bodies with the acceptance of manufacturing site as gmp/glp compliant.
We qualify the synthesized compounds for identification/structure elucidation and qualification by
infra red spectroscopy (ir)
purity/potency is defined bymass balance method usingchromatographic purity and tga data.
Isotope labelledcompounds are qualified for their isotopic enrichment.
Drug working standards are qualified against usp/bp/ep/ip reference standards.
There are quality checks at each step of the process till the product is delivered to customer.
At simson each department from r&d , purchase, marketing, logistics, follows a set of sops, which assures the quality of service.