SimSon Laboratories provides testing
services like method development, method validation and
onsite laboratory operation and management services for
a variety of projects regardless of scope or complexity.
• Analytical Method Development /Validation
• Stability testing and assessment for Drug substance
and Drug product.
• Dissolution testing
• Residual solvents analysis
• Ions estimation by Ion chromatography.
• Impurity identification by LCMS
• Impurity isolation by preparative HPLC.
• Hygroscopicity studies
speciality at low prices:
• Mass spectral analysis
• Particle Size Analysis
Synthesis Solutions :
Laboratories with its chemistry expertise offer the following:
Research and development of synthesis for the production
of the most complex molecules. Complete literature searches,
ensuring that the most efficient synthetic route has been
created and standardized.
Small-scale and large-scale chemistry capabilities. From
milligrams to multi-kilograms, we can take your projects
from concept to commercial.
Custom synthesis request:
• Small Molecules
• Complex Intermediates
• Drug Reference Compounds
• Drug Impurities
• Drug Metabolites
• Literature and Non-literature Compounds
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
• DCGI documents
• CDTL documents
• CTD and e CTD
• ANDA Submissions
• USFDA/COS Queries
• Pre Clinical and Clinical expert reports
Services (Quality Assurance) :
CMC (Chemistry, Manufacturing, and Control) expertise
includes controlling technical operations concerning drug
development including R & D and manufacturing,. Our
technical expertise includes effective management of technical
operations at R & D, manufacturing, for QMS (Quality
Management Systems), physical and chemical characterization,
pre-formulation, formulation, API sourcing and development
of product line extension based on non-infringing technologies.
• QA Systems
• Quality Manual
• Site Master Plan
• Document management system.
• Standard Operating Procedures (SOPs).
• Compliance Management.
• Training programme.
• Change control System.
• Self inspection
• Review and evaluation of production & laboratory
• Safety Policy.
• Environmental Policy.
also provide services for Toxicological Studies
• Local Toxicity studies
• Sub-Acute Toxicity Studies
• Genotoxicity Studies
Listed Drugs/Innovator Products Procurement :
can provide services for procuring Reference Listed Drugs/Innovator
Products from US, Europe, Australia etc. through our partners.