Quality Context provided development project management support and technical advice to a virtual pharmaceutical company wishing to develop a solid dose formulation with an Indian Contract Manufacturing Organisation.

Scope

We were tasked with:

  • Providing technical guidance and troubleshooting advice for a tablet development project.
  • Liaising with the client and the CMO on a regular basis to monitor project activities and keep the tasks on track with required timings.
  • Ensuring that the development work and any associated validation protocols, validation reports, stability protocols and transportation studies were fully reviewed and approved for compliance with EU GMP and ICH requirements.

Solution

Deliverables:

  • A comprehensive project plan to ensure that key deliverables and project milestones were understood by all team members.
  • Proactive technical project management, delivered via telecons, email communication and face to face meetings.
  • A comprehensive audit trail of documentation to support development and validation activities, including detailed minutes of weekly project meetings.
  • Attendance certificates for all trainees.

Success

  • Key project milestones for formulation development, analytical development and stability study set down were adhered to despite technical challenges encountered along the way.
  • We received very positive feedback from the client in relation to both the technical advice offered and the manner in which the project was managed.

To find out more about how we could support you please click here to email us for more information.