About our Company and Our Proposal “Hailwell” LLC is a company of persons holding the same views and skilled specialists. Due to the high level of service and individual selection of private arrangements for each client, we give assistance to companies to develop business providing a complex of services which allows the companies to control each stage of the process beginning from the development till brining a product into the market of interest including development of the regulatory and clinical strategy, preparation, control of the registration process, approval for medical use, compliance verification, certification of the production in compliance with GMP (PIC/S), brining products to market. Along with that, we provide services on arranging preclinical and clinical trials, the GMP (PIC/S) compliance certification, registration of medicinal products, dietary supplements and devices and other, meeting the requirements of regulatory authority in relation to pharmacovigilance and the quality monitoring.
Preclinical Trials “Hailwell” LLC can offer You a full or partial range of services on carrying out preclinical trials in Ukraine.
Clinical Trials “Hailwell” LLC can offer You a full or partial range of services on carrying out clinical trials in Ukraine.
GMP (PIC/S) Compliance Certification Since 2011, Ukraine is a country-member of PIC/S ( https: www.picscheme.org/) , the international instrument of interaction between countries and competent authority in monitoring of the medicinal products quality (domestic pharmaceutical inspectors), which together provide active and positive cooperation in complying with the requirements of good manufacturing practice (GMP) by means of inspecting and licensing production.
Registration Our company professionally performs works on registration, safety management and control of medicinal products in Ukraine. In dependence to Your needs, we are ready to offer You as a full range of works to meet all regulatory requirements so any part of it.