Services

FivePharma is an Irish company incorporated in 2003 offering tailored solutions to the pharmaceutical and allied sectors.

Auditing

  • EU GMP Volume 4 Part 1 for drug products,
  • EU GMP Volume 4 Part 2 for drug substances,
  • EU GMP for Investigational Medicinal Products,
  • EU Good Distribution Practices,
  • EU Good Clinical Practices
  • ISO9001
  • ISO13485
  • ISO17025.
  • ISO19011

Consulting

FivePharma offers Consulting Services to the Pharmaceutical and Allied Sectors on all aspects of GMP and GDP as well as IMP and Commercial Product Importation. Please contact us for further information

EU IMP and Commercial Medicinal Product Importation

  • EU IMP Importation and QP Certification
  • EU Commercial Batch QP Certification
  • EU IMP and Commercial Batch Testing
  • EU Product Distribution

Qualified Persons

  • Provide Qualified Persons per EU requirements (Article 51 of EC Directive 2001/83/EC and Article 55 of EC Directive 2001/82/EC)
  • QPs available for Registered (Commercial) batch certification
  • QPs available for Investigational Medicinal Product certification
  • Available for consultancy or batch certification
  • Available on Short or Long Term Contracts

Auditing

Training

Consulting

EU IMP Importation

Qualified Persons

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