PSNResearch supports clinical research focused on ATMPs development at different levels.

 

 

Specialized on consulting services on ATMPs regulatory framework: authorization for GMO voluntary release, preparation or review of clinical regulatory documentation, support on the design of early clinical trials, specialized service on Good Distribution Practice, risk based monitoring, management of Orphan Drug Designations by EMA and FDA.

 

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  • CLINICAL EXPERTISE ON GENE AND CELL THERAPY CLINICAL TRIALS:

 

Traumatic spinal cord injury. Liver regeneration in patients with hepatic space occupying lesion. Critical lower limb ischemia in patients with type 2 diabetes. Chronic graft against host disease. Chronic heart attack Previous and Depression Severe Left Ventricular Function. SanfilippoA. SanfilippoB. Acute Intermittent Porphyria. Liver cirrhosis. Genetic disorders. Peripheral Arterial Disease (PAD). Hereditary Angioedema (HAE). Complex Regional Pain Syndrome (CRPS). Vascular Trauma.  Ligneous Conjunctivitis.  Hemophilia. Primary Immunedeficiency Diseases (PIDD).  Nerve repair.

  • REGULATORY EXPERTISE:

 

♦ (EC) No 1394/2007: Common European regulatory framework for the marketing of ATMPs. Specialized guidelines for gene therapy, cell therapy, tissue engineering and combined products.

♦ General consultancy services at different stages: ATMP classification, scientific advice, protocol assistance, centralized procedure for MAA.

♦ Specific knowledge of national GMOs procedures for clinical trials

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