Biotechnology - , Illinois, United States
We provide full-service regulatory, quality , clinical and product development consulting services for and medical devices biologics, pharmaceuticals. Our extensive team of experts provide world-class service to clients large and small, for wide range of products, including active implantable devices for USA EU, CIS, Asia, Latin America, Australia, Canada, Japan as well as for borderline products (drug-device, cosmetics, disinfectants).Our services include:• Regulatory Strategy & Due Diligence• FDA Meeting Preparation & Engagement• FDA Submissions• Combination Products• In Vitro & Companion Diagnostics• Quality Systems & Training• Quality Audits• Clinical Development - Regulatory Assignments• Reimbursement SolutionsFor more information please contact: y_galynsky@hotmail.com