Helin Pharma
Services
PRECLINICAL STUDIES
Conducting preclinical and clinical studies according to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Iran Food and Drug Administration (IFDA) regulations:
ANIMAL MODELS
HISTOPATHOLOGY AND TOXICITY
BIOAVALIBILITY
DOSE FINDING
CLEAN ROOM DESIGN AND IMPLEMENTATION
Feasibility studies and preparation of feasibility studies (FS) for various pharmaceutical, medical and cosmetic production site.
Preparation of site plan and establishment of project workshop and implementation of construction phases.
Preparation of all GMP maps of the production site and obtaining approval from the Food and Drug Administration
Preparation of all conceptual, basic and detailed designs
Design and implementation of electrical and mechanical installations
Preparation of URS and purchase of all site construction materials and production equipment from reputable suppliers along with documentation
Validation, preparation and collection of all IQ-OQ-PQ documents and records
Installation of production equipment, water system, steel piping, material transfer lines and facilities