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.
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.
(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
Data Protection: PSNResearch collects, stores and processes data exclusively for the purpose of business operation and according to PSNResearch’s Data Protection Policy. Any personal information submitted to PSNResearch on the contact form is used and stored as an e-mail. PSNResearch will only store your e-mail data for as long as is necessary for the purpose of business operation. When this purpose is no longer relevant the data sets will be deleted as part of PSNResearch’s routine operations.