Pharma / Medical / CMO
You have a plastic component or device to manufacture, usually through a contract moulder. You understand regulatory requirements but need someone who speaks both languages — moulding process and validation. That's where we fit.
URS Drafting
Draft User Requirement Specification for a moulded component or process — written to the standard your QA team expects.
You send
Product requirements
Regulatory context
You receive
Draft URS document
Ready for QA review
Supplier / Toolmaker Selection
Technical assessment of potential suppliers or toolmakers — longlist to shortlist with written rationale and recommendation.
You send
Part drawing
Volume + regulatory requirements
You receive
Assessed shortlist
Written recommendation
Validation Protocol (IQ/OQ/PQ)
Draft validation protocols for a regulated moulding process — ready for QA review and execution. MDR and GMP context understood.
You send
Equipment list
Process info + risk assessment
You receive
Draft protocol(s)
Ready for QA review
Supplier Audit Preparation
Audit checklist, question set, and pre-audit briefing document tailored to your supplier type, product, and applicable standards.
You send
Supplier details
Applicable standards
You receive
Audit checklist + question set
Pre-audit briefing doc
CMO Technical Oversight
Ongoing remote technical point of contact between you and your contract moulder — process queries, deviations, change assessments, written responses.
You send
Drawings, deviations
Process queries from CMO
You receive
Technical responses
Change assessments