Our Pharmaceutical services

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Product Development

Health Authority meetings

Chemistry, Manufacturing and Controls (CMC) solutions

IB and IMPD writing
ASMF, DMF and CEP writing
Gap analysis/Due diligence
PRIME (priority medicines) scheme
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Registration

CTD Writing

Management of Registration procedure

Product informationand Labelling

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Early Access to Market

EAP Application Writing

Management of EAP Authorisation procedures

Exploitant servicesfor France

Management of EAP programmes in Europe

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Commercialization

Variations, renewals and MA transfer

Promotional material review & Sign Off

Compliance with Healthcare Professionals

Quality System and Audit

Exploitant status for France

Other Expertises

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Biological Evaluation, Clinical Evaluation, Risk Management, GSPR, Usability, Design & Manufacturing are our proposed Solutions

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Notified Bodies Meetings and audits

SME representation or SME registration support

Looking to enter the EU market?
Contact us today.

Contact us