We offer 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.
- Design of blinding/masking strategies for IMP.
- Manufacturing of IMP, including placebo.
- Labeling and packaging (primary and secondary) of IMP.
- Storage of IMP from -80ºC to room temperature.
- Distribution of IMP among clinical trial sites.
- Management of the return, accountability and destruction of medication used in clinical trials.