We offer expert regulatory services tailored to help businesses thrive in today's competitive landscape.
Regulatory Affairs Strategy, Project Management & Procedural Support
Company Representation
Wide experience representing companies with Health Authorities:
Unicentrix consultants have in-depth knowledge and experience with New Registration and Post-approval variations and supplements, response writing, coordination and submission planning in the following Global markets:
CMC:
Product Information:
Regulatory Compliance and Conformance:
Starting from Regulatory strategy, Planning, Intelligence, Project Management and Overall Delivery
HA Scientific advice
In-licensing/ Out-licensing
Due diligence, Dossier audits, Dossier harmonization, Divestments/ Cancellations
Site/ Source transfer.
EU Marketing Authorisation Applications (MAA)
US NDA/ BLA, Canada NDS/ BLS
UK and Ireland Regulatory affiliate activities and product launch
UK Reclassification Applications POM to P and P to GSL
Variations: CMC, Clinical, Safety, Product Information update.
US FDA Annual Reports
Renewals
Seven geographical areas Non-EU Europe, CIS, Middle East, Africa, Latin America, South Asia, Asia Pacific and China.
Authoring and review of Module 3
3.P Drug Product
3.S Drug Substance
2.3 Quality Overall Summary (QoS)
CMC
Product Information/ Labelling
We specialise exclusively in recruitment for the pharmaceutical industry, providing tailored solutions for companies seeking top-tier professionals:
Regulatory Affairs
Clinical
Quality
Technical and Medical Writing
Drug Safety and Pharmacoviligance
More coming soon. Watch this space.
