Clinreg Partners

Chief Principal Advisor, Global Clinical Regulatory Affairs. Member of FDA Advisory Committee for the Pharmaceutical Science and Clinical Pharmacology : • Review and Assess Current State of Your Regulatory Journey and Provide Strategic and Operational Advice & Gap Analysis • Analysis of Regulatory Frameworks & Requirements • Writing Clinical Protocols & Clinical Evaluations • Preparation of Regulatory Submissions such as IND and NDA • Preparation of FDA Meeting Requests and Briefing Documents • Building Quality Management Systems • Development of Target Profile and Labeling Strategy • Represent your company to different Regulatory Agencies Our Mission is to help our clients bring promising products into the market as quickly as possible ensuring regulations compliance, in order to help patients in need who may not have any other option available to them. ClinReg Partners Advisors are committed to the success of your products and provides experts in developing and implementing required regulatory and quality solutions for your needs. Our team of experts bring several years of combined experience in Regulatory Affairs, Quality Assurance, and Clinical Research with a proven track record of executing global strategy techniques in a timely and cost-efficient manner. Our expert advisors have years of experience working with many small to large companies, advising on the US FDA, and EU Competent Authorities Marketing authorization process. With our experience, regardless of where you are in the process of your drug development, we are well equipped to provide clinical research advise and regulatory strategy for successful IND, CTA, and NDA applications. Our team of experts have experience in many different therapeutic areas such as oncology, cardiovascular, dermatology, gastroenterology, orthopedic, and more.