Mannin Regulatory Limited
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Regulatory Affairs Consultancy & Training services

Mannin Regulatory Ltd is owned and run by Dr Jill Bunyan, Regulatory Affairs Consultant.

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For all your European regulatory requirements including:

  • Training programmes in all aspects of Regulatory Affairs for new or experienced staff
  • Strategic advice, particularly for Generic products
  • Preparation of regulatory dossiers for European markets
  • Management of National, Mutual Recognition (MRP), Decentralised (DCP) and Centralised licensing
  • Preparation and signature of Quality Overall Summaries, Nonclinical and Clinical Overviews and Summaries
  • Formatting or reformatting of dossiers into CTD, NeeS and eCTD format
  • Licence variations & renewals
  • Change of Ownership applications
  • Advice on and preparation of SmPCs, labelling and leaflets
  • Free Sales Certificate Applications
  • Liaison with Regulatory Authorities
  • Dossier audits & Due diligence
  • CMC advice
  • Medical Device Clinical Evaluation reports
  • Cosmetics Safety Assessments


If there are any additional services which would be of interest please do not hesitate to contact us using the form provided.
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