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HERO ā QC analyst at the instrument bench Ā·
1840Ć620
Home / Quality system
Pharmaceutical Quality Assurance & Control
Our commitment to quality, regulatory compliance and continuous improvement ensures reliable, consistent and scientifically sound pharmaceutical research solutions.
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.
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 ā 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 ā 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.
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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+91 22 4006 8689 / 4014
8689
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