Formulation Development :

We have a state of the art research lab to handle a wide range of scientific formulation development with supporting analytical testing. We have designed and developed a diversified group of drug products using wide range of technologies.

The challenge of accelerating product development while controlling costs is a difficult balancing act for the generic Pharmaceutical industry Our capabilities can deliver end-to-end solutions that fit precisely with our client needs, irrespective of the size or complexity of their undertakings.

With strong Formulation development strength, we can develop the drug delivery systems:
• Tablets ( Immediate, Extended and Delayed Release )
• Capsules( Immediate, Extended and Delayed Release )
• Liquids (Solutions, Suspensions, Emulsions)
• Parental ( Lyophilised and liquids)
• Powder for Oral Suspension

 Analytical Development :

SimSon Laboratories is a full-services providing and analytical testing firm operating with a network of laboratories. Our fully equipped analytical laboratories with the latest analytical instrument help to accelerate formulation development efforts.
 



 
 
 

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

Our speciality at low prices:
• 1HNMR
• 13CNMR
• Mass spectral analysis
• LCMS/MS
• FTIR
• DSC
• XRD
• Particle Size Analysis


 Custom Synthesis Solutions :

Simson 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.

Typical Custom synthesis request:
• Small Molecules
• API's
• Complex Intermediates
• Drug Reference Compounds
• Drug Impurities
• Drug Metabolites
• Literature and Non-literature Compounds

 Regulatory Solutions :

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.
• DCGI documents
• CDTL documents
• DMF/COS
• CTD and e CTD
• ANDA Submissions
• USFDA/COS Queries
• Pre Clinical and Clinical expert reports
 cGMP/GLP Services (Quality Assurance) :

Our 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 data.
• Safety Policy.
• Environmental Policy.

 Toxicological Studies :

We also provide services for Toxicological Studies
• Local Toxicity studies
• Sub-Acute Toxicity Studies
• Genotoxicity Studies

 Reference Listed Drugs/Innovator Products Procurement :

We can provide services for procuring Reference Listed Drugs/Innovator Products from US, Europe, Australia etc. through our partners.