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3R PHARMA CONSULTING

Regulatory and Drug Development Advisory Service

More info about 3R PHARMA CONSULTING

3R Pharma Consulting Services

3R PHARMA CONSULTING

3R PHARMA CONSULTING reviews and comments on draft documents and dossiers with regard to a planned submission of a regulatory application, listing the major gaps that should be closed prior to the filing.

The company generates regulatory documents such as:

  • Common technical document (CTD) Module 3
  • Quality overall summaries for CTD Module 2
  • Summaries for scientific advice meetings

GMP Audits

3R PHARMA CONSULTING also provides guidance on meeting the requirements of a wide range of audits, including:

  • Good manufacturing practice (GMP) audit of active pharmaceutical ingredient (API) manufacturers (ICH Q7)
  • GMP audits of manufacturers of medicinal products and contract labs
  • Audits of wholesalers and distributors meeting good distribution practice (GDP) standards
  • Mock inspections
  • GMP advice and training
  • Corrective and preventative action (CAPA) investigations

Basic introductory courses (in-house or in public)

3R PHARMA CONSULTING’s basic introductory courses include:

  • Chemistry, manufacturing and control (CMC) topics in pharmaceutical development
  • Stability testing, including the design of cost-effective stability protocols and statistical analysis of stability data
  • CTD Module 3 Quality (ICH Guideline M4-Q)
  • Quality by design (QbD), real-time release (RTR), design space and Fisher`s design of experiments (DoE)

Specialised in-house training courses or workshops

3R PHARMA CONSULTING’s more advanced in-house training courses and workshops are customised to meet client requirements. These include:

  • Chemistry, manufacturing and control (CMC) topics in pharmaceutical development
  • Stability testing, including the┬ádesign of cost-effective stability protocols and statistical analysis of stability data
  • CTD Module 3 – Quality (ICH Guideline M4-Q)
  • Quality by design (QbD), real time release (RTR), design space and Fisher`s design of experiments (DoE)
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