Hugh Delargy Associates Ltd

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Hugh Delargy Associates Limited is a pharmaceutical regulatory consultancy specialising in European CMC (Chemistry, Manufacturing and Control) subjects.

Hugh Delargy is the Principal Consultant and his past experience as UK licensing assessor at the MHRA and current role as a Quality Assessor on the WHO Prequalification Programme enables him to provide valuable insight to his clients working on products for clinical trial approvals and marketing authorisations in the EU.  More

Consultancy services include licensing strategy, scientific advice, submission of applications (CTAs and MAAs) and maintenance of approvals

Pharmaceutical regulatory, scientific and technical advice on

• new active substances including first in class
• investigational medicinal products (IMPDs)
• existing active substances
• line extensions
• generic applications
• variation applications

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