Manufacturing Process Design and Control

To compliment the formulation development services, H2 Pharma provides specialised consultancy in manufacturing process design, control and technical problem-solving.

We provide practical solutions to process challenges and assist Clients with the construction, implementation and management of all aspects of the process development plan.

We adopt industrially-recognised risk-assessment tools and assist Clients with the utility of these tools throughout the product development life-cycle.

Our services include:

  • Risk analysis of manufacturing processes (FMEA, Britest)
  • Development of process plans and design of experiments
  • Practical guidance on utility of “Quality-by-Design” principles
  • Interpretation and application of ICH-Q8 and -Q9 guidances
  • Development of Process Analytical Technology (PAT) strategies

Consultancy Services