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Method Development & Validation

GBA Group - Method Development and Validation

A lot of facts have to be considered

The development and validation of a new method often seems to be hard and complex. Prior to the start, a lot of facts have to be considered. Beneath the availability of qualified personal the performance of the new method has to meet internal and general quality guidelines and should be suitable for everyday use. Especially with biotherapeutics, you are forced to follow new analytical paths, as new synthetic pathways are explored continuously.

Save time, money and own resources, which might be used more efficiently elsewhere. Take advantage of the know-how and the capacity of the GBA Group.

In the field of human and veterinary drugs, biologic therapies and herbal medicines we offer.

Development and Validation of New Analytical Methods for:

  • APIs and Raw Materials used for Pharmaceutics and Biotherapeutics
  • Chemically Defined Substances
  • Medical Devices

Development and Validation of Impurity Testing

  • Degradation Products in Finished Formulations
  • By-Products Resulting from Synthesis of Active Substances made for Pharmaceutics and Biotherapeutics
  • Trace Components and Detergents (Tween, Pluronic, Triton, etc.)
  • Forced degradation studies

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs - GMP Testing

GBA Pharma Labs – GMP Testing

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GBA Pharma Labs - GMP Quality Control

GMP Quality Control

GBA Pharma Labs - Method Development & Validation

Method Development & Validation

GBA Pharma Labs - Stability Studies

Stability Studies

GBA Pharma Labs - Dissolution

Dissolution

GBA Pharma Labs - Extractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Packaging Material Testing

Packaging Material Testing

GBA Pharma Labs - Particle Determination

Particle Determination

GBA Pharma Labs - Elemental Impurities Testing

Elemental Impurities Testing

GBA Pharma Labs - Microbiology

Microbiology

GBA Pharma Labs - Regulatory Services

Regulatory Services

GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

GBA Pharma Labs - Instrumentation

Instrumentation

GBA Pharma Labs - N-nitrosamines

N-nitrosamines

GBA Pharma Labs - qPCR

qPCR

GBA Pharma Labs - iCEF

cIEF

GBA Pharma Labs - Protein characterization

Protein Characterization

GBA Pharma Labs - Limit test for DEG and EG by GC

Limit test for DEG and EG by GC

GMP Testing

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