Jarosz Regulatory Services, Inc. Staff

Jarosz Regulatory Services, Inc. maintains close working relationships with the following affiliate consultants. We work together to produce superior quality regulatory and medical writing services. Jarosz Regulatory Services, Inc. affiliates are highly regarded professionals and seamlessly compliment the services that we bring to our clients.

   Taylor & Associates, LLC

Amy Taylor

Ms. Taylor is a principal consultant and founder of Taylor & Associates, LLC. She has over 20 years of healthcare industry experience in regulatory affairs, product development, quality assurance, and manufacturing disciplines. Ms. Taylor has in-depth knowledge of product development requirements for both pharmaceuticals and medical devices. Ms. Taylor has experience in regulatory strategy and submissions, with an emphasis in CMC issues.

   ARx Pharmaceutical Regulatory Consultancy LLC

Amanda M. Radspinner, Ph.D., RAC

Amanda M. Radspinner, Ph.D., RAC has almost ten years experience in the pharmaceutical industry both in the US and abroad. This includes over eight years experience with approval and postapproval regulatory CMC submissions, as well as extensive experience in developing and preparing CMC sections for investigational drug substances and drug products. Amanda has worked with domestic and foreign companies in all facets of drug development, approval, and maintenance, including preparation of drug master files (US, European, Canadian, and Australian), as well as CMC sections of INDs, IMPDs, NDAs, MAAs, and postapproval submissions (PASs, CBE-30s, CBEs, and ARs, as well as Type 1a/1b/2 Variations). Amanda has also worked with various pharmaceutical companies to custom design various regulatory compliance tools to improve the efficiency of RA and site personnel. Amanda is well versed in CTD, and has converted many historical submissions to this format. By keeping in mind the many recent developments in the Pharmaceutical Industry, including ICH Q8, Q9, and PAT, she is committed to working with pharmaceutical companies to improve how drug products are developed and submitted to Regulatory Authorities, such that the development and approval process are rational, and the regulatory approval of such products realizes the promise of regulatory flexibility.

   Quality and Regulatory Associates LLC

Gary Syring, PE, RAC

Gary Syring founded Quality and Regulatory Associates (QRA) to specialize in supporting medical device businesses with quality system and regulatory affairs issues. Gary Syring has over 25 years of medical device experience and is a registered Professional Engineer. Support services provided include FDA Quality System Regulation (QSR) development and compliance, international quality system development and compliance, Medical Device Directive conformance, development and implementation of FDA pre-marketing submissions and European Directives submissions.

   Adriana Rosado & Bonewitz, Inc.

R. F. Derick Bonewitz, Ph.D.

Dr. Bonewitz is the President of Adriana Rosado & Bonewitz, Inc., a translation, editorial, and cultural training service in Spanish and English. He has extensive training and experience in science and technology with emphasis in healthcare. Dr. 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 for over 35 years.

L. Adriana Rosado-Bonewitz

Ms. Rosado-Bonewitz is the Vice-President of Adriana Rosado & Bonewitz, Inc., a translation, editorial, and cultural training service in Spanish and English. She has gained considerable multicultural experience and has worked as a correspondent for a major U.S. healthcare company with responsibility for several Latin American countries, Canada, Japan, New Zealand, and Australia. Ms. Rosado-Bonewitz founded her translation company in 1992 and was the recipient of the 1998 LUCI award to leading businesswomen in Lake County, Illinois.

	Jarosz Regulatory Services, Inc. maintains close working relationships with the following affiliate consultants. We work together to produce superior quality regulatory and medical writing services. Jarosz Regulatory Services, Inc. affiliates are highly regarded professionals and seamlessly compliment the services that we bring to our clients.
	Taylor & Associates, LLC
		Amy Taylor
		Ms. Taylor is a principal consultant and founder of Taylor & Associates, LLC. She has over 20 years of healthcare industry experience in regulatory affairs, product development, quality assurance, and manufacturing disciplines. Ms. Taylor has in-depth knowledge of product development requirements for both pharmaceuticals and medical devices. Ms. Taylor has experience in regulatory strategy and submissions, with an emphasis in CMC issues.
	ARx Pharmaceutical Regulatory Consultancy LLC
		Amanda M. Radspinner, Ph.D., RAC
		Amanda M. Radspinner, Ph.D., RAC has almost ten years experience in the pharmaceutical industry both in the US and abroad. This includes over eight years experience with approval and postapproval regulatory CMC submissions, as well as extensive experience in developing and preparing CMC sections for investigational drug substances and drug products. Amanda has worked with domestic and foreign companies in all facets of drug development, approval, and maintenance, including preparation of drug master files (US, European, Canadian, and Australian), as well as CMC sections of INDs, IMPDs, NDAs, MAAs, and postapproval submissions (PASs, CBE-30s, CBEs, and ARs, as well as Type 1a/1b/2 Variations). Amanda has also worked with various pharmaceutical companies to custom design various regulatory compliance tools to improve the efficiency of RA and site personnel. Amanda is well versed in CTD, and has converted many historical submissions to this format. By keeping in mind the many recent developments in the Pharmaceutical Industry, including ICH Q8, Q9, and PAT, she is committed to working with pharmaceutical companies to improve how drug products are developed and submitted to Regulatory Authorities, such that the development and approval process are rational, and the regulatory approval of such products realizes the promise of regulatory flexibility.
	Quality and Regulatory Associates LLC
		Gary Syring, PE, RAC
		Gary Syring founded Quality and Regulatory Associates (QRA) to specialize in supporting medical device businesses with quality system and regulatory affairs issues. Gary Syring has over 25 years of medical device experience and is a registered Professional Engineer. Support services provided include FDA Quality System Regulation (QSR) development and compliance, international quality system development and compliance, Medical Device Directive conformance, development and implementation of FDA pre-marketing submissions and European Directives submissions.
	Adriana Rosado & Bonewitz, Inc.
		R. F. Derick Bonewitz, Ph.D.
		Dr. Bonewitz is the President of Adriana Rosado & Bonewitz, Inc., a translation, editorial, and cultural training service in Spanish and English. He has extensive training and experience in science and technology with emphasis in healthcare. Dr. 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 for over 35 years.
		L. Adriana Rosado-Bonewitz
		Ms. Rosado-Bonewitz is the Vice-President of Adriana Rosado & Bonewitz, Inc., a translation, editorial, and cultural training service in Spanish and English. She has gained considerable multicultural experience and has worked as a correspondent for a major U.S. healthcare company with responsibility for several Latin American countries, Canada, Japan, New Zealand, and Australia. Ms. Rosado-Bonewitz founded her translation company in 1992 and was the recipient of the 1998 LUCI award to leading businesswomen in Lake County, Illinois.