PHARMEGIC

 

Pharmegic Healthcare

Pharmegic Healthcare Limited was established in May 2017 with a vision to provide cost effective, innovative, solutions for the pharmaceutical and Chemical sectors. To archive this vision, Pharmegic Healthcare Limited has set up a team of professionals with extensive experience in the global pharmaceutical & chemical industry.  Our facility operates out of the heart of Lithuania, located at 6th Floor, Konstitucijos av. 21A,Vilnius, 08130, Lithuania. From this facility, our highly experience scientific and project management teams ensure that all projects undertaken are executed in a timely, quality focused, cost effective manner while maintaining customer confidentiality and the protection of all intellectual property under development.

Our Services

REACH?

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

Client Satisfaction

Pharmegic Healthcare Limited has a strong focus on client satisfaction, safety, ethics and integrity. Our ability to deliver significant value to our customers by leveraging our scientific skills and global mind set is at the core of all project work undertaken for our customers.

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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