REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals.It came into force on 1st June 2007 and replaced a number of European Directives and Regulations with a single system.

Regulatory Consultancy

  • Regulatory strategy
  • CMC & manufacturing compliance
  • Market authorization application in EU
  • Product life cycle management
  • Dossier publishing

Medical Writing

  • Preclinical study reports
  • Clinical study reports (Phases I to IV) compliant with ICH E3 standards
  • Clinical protocols
  • Investigator brochures
  • Investigational Medicinal Product Dossier (IMPD)
  • Informed Consent Forms
  • Writing and compilation of CTD modules
  • PSURs
  • Narratives
  • Clinical and non-clinical Expert reports
  • Clinical and non-clinical overviews
  • Extensive literature search for Module 4 and 5
  • Preparation of summary of product characteristics (SmPC), patient information leaflet (PIL) in QRD format
  • Scientific and protocol advice

Research and Development

  • Development for NCES
  • Technology transfer
  • Formulation development
  • Pre-formulation services
  • Stability studies
  • Analytical development and validation

About Us

Pharmegic Healthcare Limited provides Pharma & Chemical regulatory compliance and product safety solutions globally. Pharmegic Healthcare Limited has its headquarter in Ireland and offices in India & China.

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