Built for You
(Entity & Licence Build)

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A tailored, embedded delivery model designed around your organisation. Combining the right expertise, governance, and capacity to deliver critical outcomes.

TDP’s Built for You service specialises in establishing fully licensed and commercially operational life sciences entities on behalf of organisations within the UK, EMEA, USA, APAC, LATAM, GCC. Our focus is on entity formation, Quality management process build out, regulatory licensing acquisition, and registration so clients can enter new markets quickly, confidently, and fully compliant with local and international regulations.  

By combining regulatory expertise with practical operational know-how legal and local expertise, TDP ensures that newly formed entities are inspection-ready, fully licensed, and aligned with all applicable local and international requirements across GCP, GMP, GDP and combination drug and device products. This reduces risk, accelerates market entry, and eliminates the need for clients to build complex infrastructure internally.

BEST FOR

Complex programmes needing multi-disciplinary delivery (QA/RA/Compliance)

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Organisations with unique constraints, timelines, or operating models

Teams that want a long-term partner with real ownership

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WHAT’S INCLUDED

Discovery and design of the delivery model (scope, roles, cadence)

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Embedded expertise aligned to your workstreams and priorities

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Governance: reporting, action tracking, escalation paths, decision logs

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Documented outputs and evidence trails (inspection-ready)

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Stakeholder management across internal teams and external partners

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Flexible resourcing as priorities shift

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Continuous improvement: what’s working, what’s not, what changes next

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HOW IT WORKS

Define outcomes and constraints (time, risk, resources)

❶

Build the model: scope, team, governance, ways of working

❷

Deliver with structured reporting and clear outputs

❸

Review and refine as the business evolves

❹

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