CONSULTING

Expertise. Intuition. Ingenuity.

Our Services.

Consulting Solutions within Pharmaceutical and Energy Infrastructures  Sectors.

Pharmaceutical Industry

Energy & Infrastructure

Services
Pharmaceutical Industry.

Consulting in the process of establishing quality management system according to national and international standards (ISO 9001, ISO 14001, ISO 18001, cGMP)

  • Development of finished dosageforms and reformulation of the existing formulas (solids, semisolids and liquids; Rx and OTC drugs, medical devices, dietary supplements, cosmetics),
  • Analytical method development, method upgrades and method validation
  • In vitro testing
  • Technology transfer and analytical method transfer
  • Stability tests in accordance with ICH guidelines
  • Packaging technology and primary packaging material proposals
  • Manufacturing and packaging of bulk products
  • Serialisation
  • Validation of chambers (air condition, fridges, autoclaves)
  • Preparation of specifications of user requests and risk analysis for procurement of manufacturing equipment, measuring instruments etc.
  • Evaluation of offers, installation and qualification of equipment, measuring instruments etc.
  • Preparation of patterns for
    blister machines
  • Regulatory Strategy, Guidance & Support
  • Registration dossier development and upgrade (Module 1- Module 5)
  • Advice on national or EU regulation for drugs and medical devices
  • Compilation and submission of Marketing Authorisation applications /renewal applications to Regulatory Authorities
  • Medical writing and updating (labelling, leaflets and SmPC)Regulatory compliance for food supplements and cosmetics
  • Pharmacovigilance
  • Preparation and submissions for regulatory approvals for clinical studies
  • Review (regulatory requirements) and submission of promotional materials to Regulatory Authorities
Services
Energy & Infrastructure.

In the consulting industry, each situation is unique and requires a specific set of solutions.

Five4 Consulting provides financial and technical advise on energy projects in and outside the UK.

We help our clients set up a medium-long term plan and then we provide expert advice and strategic planning to help them with implementation.

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