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Regulatory support and logistics in clinical research

We offer to our clients regulatory consulting and logistics management of clinical trials, a complementary service to the activities performed by CROs for clinical research.

  • • Preparation of the Investigational Medicinal Product Dossier (IMPD).
  • • Preparation of Investigator's Brochure (IB).
  • • Preparation of clinical trials applications to be submitted to Institutional Review Board / Independent Ethics Committee (IRB/IEC) or to the Competent Authorities.
  • • Texts design for the labeling of Investigational Medicinal Products (IMP) according to Annex 13 of GMP.
  • • Strategy design s for the blinding/masking of Investigational Medicinal Products.
  • • Manufacturing management for investigational medicinal products (own or outsourced) including placebo.
  • • Labeling and packaging (primary and secondary) of investigational medicinal products.
  • • Storage of investigational medicinal products.
  • • Distribution of the investigational medicinal product among clinical trial sites.
  • • Management of the return, accountability and destruction of medication used in clinical trials.
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