Services

Technical Services

Our technical services for industries in the fields of biotech, pharmaceutical, medical devices, and other manufacturing operations are guided by the highest standards, as established by regulatory agencies (FDA) and following GMP across all of our processes.

Product Transfer / Analytical Method Transfer Activities

At Principia Inc., we are here to guide and manage your Product Transfer Activities by employing
world-class methodologies and techniques, which have positively affected organizational culture
to ensure a smooth product transfer and analytical transfer activities.

Principia Inc. can offer a broad range of services executing roles with direct experience in
new product development, product improvement, inventory planning, project management, production
start-up, production scale-up, product transfer, analytical transfer, plant closing, controlled
substance products.

Our talented staff posed strong experience at the domestic and international level with proven
track record of solid performance in the product registration in EU/LATAM/Japan/Korea.

Our services include:

  • Project scope generation for product and analytical method transfer activities.
  • Generation, revision and approval of the Project Charter.
  • Generation, revision and approval of the technology transfer documentation package.
  • Coordination of a project kick-off meeting.
  • Preparation and Update of Project Execution Plan and Project Integrated Schedule.
  • Coordination and meeting with sending and receiving site.
  • Support to the product transfer activities with required departments the execution of the
    studies.
  • Requests product and process information from the Sending Site by review and acceptance of
    the Receiving Site to ensure that the information received is complete and adequate to
    support the process transfer and commercial manufacture.
  • Generation of robust and comprehensive GAP analysis and to identify of all tasks required.
  • Identify potential obstacles and brings forward potential solutions for approval by management.
  • Update Management on all potential delays, issues and budget overruns. Evaluate effect of
    these issues on the overall timing of the project. Make recommendations to management
    on how to resolve and continue.
  • Coordinates the transfer and distribution of documents and samples as needed to complete
    the Product Transfer Activities.
  • Work closely with internal and external team members to manage the technical transfer of
    analytical methods, formulation instructions and manufacturing processes from R&D to
    external manufacturing and packaging sites.
  • Serve as primary contact for outside partners and provide guidance to expedite transfers
    and finalize projects for ANDA submissions.
  • Assigns post-transfer responsibilities, as appropriate.

Packaging Technical Services

At Principia Inc. our Packaging Technical Services Area offers a broad range of services
in support of packaging operations. Principia can support a Packaging project from conceptual
design through validation. Principia provides an assessment of Packaging lines to identify
performance improvements and recommends either equipment modification or operational
changes.

Our services include: