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Analytical development and Validation Services

SERVICES

Analytical development and Validation Services

   To ensure that your initiatives are well-rounded, AARSH Pharmaceuticals has a team of experts who are familiar with international quality standards and regulatory requirements. Our cutting-edge analytical lab allows us to create a wide range of analytical procedures. The analytical approach is planned according to the project lifecycle and the demands of the client. Isolation, identification, and characterisation of nitrosamine and other genotoxic impurities, as well as their evaluation, are all part of our impurity profiling capabilities, which extend to method validation, development, and verification.

In accordance with ICH standards, we also do stability assessments. In order to move on to the next stage of drug development, it is necessary to develop and validate analytical methods. This will guarantee that the methods are suitable for their intended use, that the results produced are solid and trustworthy, and that the drug's properties are in line with industry standards.

AARSH Pharmaceuticals has considerable experience which, coupled with advanced instrumentation, enables the development and validation of efficient, accurate, reliable and robust analytical methods.

Method Development

Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure a successful outcome. Utilising laboratories equipped with sophisticated analytical instrumentation, we can develop analytical methods suitable for all your needs.

Method Validation

The AARSH Pharmaceuticals analytical team have a comprehensive working knowledge of analytical method validation requirements that can be tailored to different phases of clinical development. To ensure methods meet regulatory requirements we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidance in combination with client-specific protocols. Comprehensive reports are provided upon completion.

Our Services

Other Services

Contract Research Activities
Industrial Training
Ph.D. and other project work support
R and D Facility
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