Outsourced Functions
(Quality, Regulatory, CMC, MS&T)
Outsourced Quality and Regulatory capability you can rely on. Providing consistent oversight, delivery, and accountability without permanent headcount.
TDP’s Outsourced Departmental Functions service provides life sciences organisations with fully operational Regulatory Affairs, Quality, CMC, and MS&T capabilities without the cost, risk, or complexity of building and maintaining internal departments. Delivered as a true extension of the client organisation, these functions are embedded into governance structures, quality systems, and day-to-day operations, ensuring seamless integration and regulatory credibility.
The service is designed for organisations operating in regulated environments that require consistent oversight, specialist expertise, and operational continuity, but where internal resourcing may be constrained by scale, maturity, or transformation activity. TDP enables clients to operate compliantly, confidently, and efficiently while retaining flexibility to scale up or down as needs evolve.
BEST FOR
Organisations needing an outsourced QA/RA function or leadership cover
Lean teams requiring stable capacity for BAU and governance
Businesses that want defined ownership and reliable delivery
WHAT’S INCLUDED
Defined outsourced scope (responsibilities, deliverables, boundaries)
Ongoing oversight across core quality systems and compliance priorities
Governance cadence: weekly actions, monthly reporting, escalation rules
Documented outputs and decision rationale
Supplier/partner coordination where relevant
Flexible capacity management (peaks and planned increases)
Handover support if you later bring capability in-house
HOW IT WORKS
Confirm what you want outsourced (and what stays in-house)
❶
Agree governance, reporting, and deliverables
❷
Operate with consistent oversight and clear outputs
❸
Scale, stabilise, or transition as needed