3R Pharma Consulting Services

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 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)