Quality Aspects

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

  • 1H-NMR
  • 13C-NMR
  • Mass Spectroscopy
  • 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.

SimSon Pharma has more than 50 scientist and chemist in the Laboratory working under the expert guidance of our Company Director. Our R&D is managed by an experienced team of professionals who have an excellent track record in product development services right from concept design to ultimate product commercialisation. SimSon’s team members brings global experience and truly understand the ever changing global requirements.

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