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EU GMP Batch Release Testing
EU QP Batch Release
Stability Testing
Analytical Methods Development and Validation
Analytical Support During Registration
Dissolution Testing
Impurities Testing
Quality Consulting Services
Research and development
Formulation Development
Quality Target Profiling
Product Characterisation
Impurities Profiling
Comparability Testing
Comparative Dissolution Testing
Melatonin Drug Product
EU GMP Batch release
EU QP Release
Stability testing
Analytical methods development and validation
Analytical support during registration
Dissolution testing
Quality Consulting services
Formulation development
Quality target profiling for biosimilars
Product characterisation
Impurity profiling
Comparability testing
Comparative dissulution testing
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Comprehensive range of quality control and development services
CoA/CoC for imported products
Batch certification of imported products
Supporting all types of stability programs
According to EMA, FDA, or ANVISA regulations
Testing for dossier-filling and support with product registration
Comparative dissolution testing and stability program’s support
Impurities profiling and routine testing
Strong expertise with quality control and EU regulations
Innovative, added value, and generic formulation development
Critical quality attributes definition and Quality by Design development
Full characterization of reference products
Impurities profiling and characterization
Demonstrating similarities with reference products
Comparative dissolution testing and media selection