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TRUSTED PARTNER FOR
REFERENCE STANDARDS & BEYOND

INNOVATION QUALITY GLOBAL IMPACT
SINCE 2007
SimSon — Science Standards Solutions SimSon Pharma Limited SimSon Has Evolved. For a Healthier World.
Home About us Products Facility Quality system Our division ā–¾ SimSon Chemtech Speciality & fine chemicals SimSon Chemie Research chemicals supply SimSon Lifescience Services CRO, CDMO & analytical testing
Home About us Products Facility Quality system OUR DIVISION SimSon Chemtech Speciality & fine chemicals SimSon Chemie Research chemicals supply SimSon Lifescience Services CRO, CDMO & analytical testing
HERO — QC analyst at the instrument bench Ā· 1840Ɨ620
Home›Quality system

Multi-level quality assurance at every step

We have multi-level of Quality Assurance at each Step of Business Process. We follow Good Laboratory Practice Guidelines

Accredited to manufacture. Accredited to test.

ISO 17034 for reference material production and ISO/IEC 17025 for testing, backed by NABL, ILAC-MRA recognition, GMP, GLP and DSIR. Open any mark to view the certificate.

The commitment every batch is measured against

ISO/IEC 17025:2005 — NABL ISO 9001:2015 ISO 17034:2016 ISO 14001:2015 OHSAS 18001:2007 GLP Certificate DSIR Certification

To develop quality, safe and efficacious Pharmaceutical Standards, Drug Materials, Drug Products, Developing Technologies in Formulation Research & Chemical Research, giving Quality Analytical Testing services by continuous monitoring of quality systems. Uphold to strict quality principles and meeting customer's expectations by involving all the Employees of the Organization.

To maintain quality system as per the requirements of the International Standard ISO/IEC 17025:2005 relevant NABL Certification, ISO 9001:2015, ISO 17034:2016, ISO 14001:2015, OHSAS 18001:2007, GLP Certificate and DSIR Certification.

Five controlled stages, one release decision

Every compound passes the same sequence, whether it is five milligrams for a method or bulk supply for a commercial programme.

Specify The impurity, metabolite or standard is defined against your method and the pharmacopoeial requirement it has to satisfy.
Synthesise Route design, isolation and purification run in our own Indian laboratories under controlled documentation.
Qualify Identity, purity and assigned value established by NMR, mass spectrometry, IR, HPLC, GC and potency by mass balance.
Document Certificate of analysis, spectral data and MSDS issued with the assigned value and its stated uncertainty.
Review Quality systems monitored continuously — ISO 17034 for production, ISO/IEC 17025 for testing.

How identity, purity and value are proven

Characterisation runs in our own laboratories and is reported in full — no assigned value without the data behind it.

NMR Structure and identity confirmed by proton and carbon NMR, with spectra supplied alongside the certificate.
Mass spectrometry Molecular mass and fragmentation confirm identity; LC-MS supports trace-level and isotope-labelled work.
Infrared (IR) Functional group confirmation as part of the identity set for every released batch.
HPLC Chromatographic purity with method details recorded on the certificate of analysis.
GC Volatile impurity and residual solvent determination where the molecule requires it.
TGA / DSC Thermal behaviour, water and solvent content, and polymorphic form characterisation.
Potency by mass balance Assigned value calculated from the full impurity, water and residual solvent picture.
Traceability Values traceable to recognised reference standards, with supporting calculations and stated uncertainty.

Documentation your dossier can rely on

Certificate of analysis Issued with every batch, on every record.
MSDS Safety documentation for handling and shipping.
NMR & spectral data Raw evidence behind the assigned identity.
Assigned value & uncertainty Traceable value with its supporting calculation.

At SimSon, we follow 3-layered packaging System:

1 For Primary Packing of All CRS, we use high Quality Glass Vials or Storage Vials. For hygroscopic and sensitive products, the vials are purged with Nitrogen or Argon.
2 These Vials are packed in a Secondary Protective HDPE Bottle.
3 These Vials are packed in Thermocol Boxes.
4 The Thermocol Box is packed in a strong protective outer carton.
5 Special Packing and Special Shipping at -20ĀŗC can be done for highly sensitive materials.
3 LEVELS OF QUALITY ASSURANCE artwork Ā· 560Ɨ420
Certificate of analysis document Ā· 560Ɨ420
Reference standard vials Ā· 560Ɨ420
Outer carton with SimSon branding Ā· 560Ɨ420

Sample structure

Illustrative image. Product structure coming soon.

Illustrative sample structure
SimSon — Science Standards Solutions
ISO 17034:2016 ISO/IEC 17025:2017 Ā· NABL GMP GLP DSIR US FDA inspected
D-U-N-S Registered — Dun & Bradstreet D-U-N-SĀ® REGISTERED Verified by Dun & Bradstreet
OFFICES & LABORATORIES
REGISTERED OFFICE Ā· MUMBAI B-307, Sarita Building, Prabhat Industrial Estate, Near Dahisar Toll Naka, Dahisar (East), Mumbai- 400068, Maharashtra, India
CORPORATE OFFICE Ā· MUMBAI Unit 1001-1006, The Platina, Tanvi Complex, S. V. Road, Dahisar East, Mumbai 400068, India
LABORATORY Ā· HYDERABAD Shed 6A, TYPE III, TSIIC, Prashanthi Nagar, Kukatpally, Hyderabad 500072, India
REGIONAL OFFICE Ā· AHMEDABAD Survey Number 375 Paiki 1, Plot Number 11, Shivam 5, Near Sumip Composite, Panchratna Estate, Village Changodar, Taluka Sanand, District Ahmedabad, Gujarat-382213
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