Over 10 years we help companies reach their financial and branding goals. Engitech is a values-driven technology agency dedicated.

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Contacts

411 University St, Seattle, USA

engitech@oceanthemes.net

+1 -800-456-478-23

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.

Technical Services

Product Transfer / Analytical Method Transfer Activities

At Principia, 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 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 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 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.
Technical Services

Packaging Technical Services

At Principia, 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:
Project Initiation and Planning
  • Project Management
  • Conceptual Design
  • Gap Assessments
  • Risk Assessments
  • Validation Master Planning (VMP)
Packaging Equipment Requirements and Design
  • User Requirements Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Design Review
  • Supplier/Vendor Audits
Equipment Development and verification
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requirements Traceability
Packaging Line Performance Evaluation
  • Develop line performance measures
  • Identify areas of improvements
  • Implementation
High-Quality Services

Our Services