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On Site Placements

On Site Placements

Through our large network of nationwide consultants we are able to provide resource for on-site projects.

Contact us to discuss your requirements…

Development

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Approval

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Post Approval

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How we work with you

TRAC provides high quality off-site regulatory affairs services using our own established, proven and highly successful outsourcing model. Having an excellent communication and IT infrastructure allows us to work as an integral part of your team; either by email, remote access, VPN or teleconference - which means that your dedicated project manager will always be close at hand.

Our large network of nationwide consultants is also available for on-site projects where this is the preferred option.

To find out more about the services that we offer please click on the relevant section of the product life cycle above.

A-Z of Services

Advertising and Promotion advice
Agency meetings
Bridging studies and reports
Centralised Submissions
Clinical Trial Applications (CTA)
Decentralised (DCP) submissions
eCTD submissions
Herbal medicines registration (THMRS)
Line extensions

Marketing authorisation applications
Mutual Recognition (MRP) submissions
National submissions
NeeS submissions
On Site Placements
Pharmacovigilance
PIL testing
PSUR
QA/QP release

Reclassification (POM - P)
Renewals
Response to questions
Substantial Amendments to Clinical
Trial Applications
SmPC composition
Variations

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