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
Global Scientificts 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.
Global Scientificts 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
Global Scientificts 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.