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.

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

Industries

Our highly skilled staff is disciplined to work within a range of industries in the dynamic life sciences sector, to meet demanding and evolving expectations.

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Process Automation

Our process and industrial automation personnel are trained to offer a broad scope of services to meet or exceed your project goals.

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Manufacturing IT

Manufacturing Execution Systems (MES) expertise to orchestrate manufacturing operations, connecting real-time data originated at the shop floor with enterprise level applications.

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