Medical And Pharmaceutical Product And Process Compliance
Principia Technica aims to support companies in their development programmes to translate their novel ideas into robust products that are manufactured efficiently under intelligent process controls and are backed up with comprehensive regulatory document packages.
Twenty years’ experience of developing and industrialising medical and pharmaceutical devices. Products range from electrosurgical tools through dry powder inhalers to smart nebulisers.
We can optimise your development, from applying appropriate design controls, executing design reviews and managing technical and programme risks through to setting up pilot- and commercial-scale manufacturing systems.
We have experience in setting up and operating design, development and documentation practices that conform to the requirements of ISO 13485 and 21.CFR.820.30
We have first-hand experience in successful Notified Body audits and FDA Pre-Approval Inspections of Medical Devices and Combination Products.
We draw upon a broad network of proven contacts to support your development programme.
We have tried and tested links with design analysis specialists, industrial design and human factors experts, prototype suppliers, test houses, pilot-scale tooling and full scale commercial manufacturers in the UK, Europe and the US.
Support In Key Areas
Regulatory-compliant design policies
Effective specification development
Procedures for: Design planning
Design history file
Independent expert in design reviews
Identification and control of critical features and quality attributes (CQA)
Quality by Design (QbD) techniques
Control of CQAs into manufacture
Design for manufacture and assembly input
Manufacturing strategy development
Manufacturing partner selection and set-up
Tooling and assembly line project management: pilot scale and high volume
Tool and moulding process validation techniques