development and in international regulatory affairs. She has focused her regulatory expertise in the international arena since 1991. Ms. Jarosz also has a considerable clinical background...Mary Y. Jarosz Mary Y. Jarosz, RPh, RAC, FTOPRA . . . is the President and Principal Consultant of Jarosz Regulatory Services, Inc. She is responsible for regulatory strategy..., submissions, and post-approval activities for drugs worldwide. Prior to founding Jarosz Regulatory Services, Inc., Ms. Jarosz worked in the pharmaceutical industry in product...

, granules, suspension, solution), sterile injectable preparations Compliance Activities Regulatory Affairs due diligence audits Document review for regulatory submissions Areas... USA Jan 1996 to present Senior Regulatory Affairs Associate Abbott Laboratories Abbott Park, IL USA Sept 1994 to Dec 1995 Regulatory Affairs Associate Abbott Laboratories Dec 1992... to Sept 1994 Regulatory Affairs Associate/Label Editor Abbott Laboratories Feb 1992 to Dec 1992 Research Pharmacist and Project Leader Abbott laboratories North Chicago, IL USA Sept...

& Approval Game Plant Master Files Drug Master Files Responses to Deficiency Letters Literature Summaries Re-Registrations Regulatory writing for submissions Regulatory Affairs...Jarosz Regulatory Services, Inc. Services Development of Regulatory Strategies Common Technical Document Clinical Trial Applications/IND Clinical/Preclinical Overviews Clinical... Tutorials Assistance with other regulatory and medical writing needs What Can You Expect From Us? Personalized attention to your regulatory needs Commitment to provide outstanding...

Discovery & Development * Development & Clinical Studies * Regulatory Review & Approval TOPRA: Worldwide Regulatory Affairs LinksThe Organisation for Professionals in Regulatory... Affairs (TOPRA, formerly ESRA and BIRA) maintains a comprehensive set of World Wide Web links of interest to Regulatory Affairs Professionals. FDA Links to Worldwide Ministries...Jarosz Regulatory Services, Inc. Resources Secure Download / Upload file transfer Web siteJarosz Regulatory Services, Inc. maintains a Download / Upload file transfer Web site...

industry experience in regulatory affairs, product development, quality assurance, and manufacturing disciplines. Ms. Taylor has in-depth knowledge of product development requirements.... Bonewitz has over 10 years of experience in regulatory affairs and has conducted business in Mexico, Europe, Japan, and Africa, and has studied Mexico and its language and culture...Jarosz Regulatory Services, Inc. Staff Jarosz Regulatory Services, Inc. maintains close working relationships with the following affiliate consultants. We work together to produce...