{"id":54393,"date":"2023-03-01T17:05:27","date_gmt":"2023-03-01T16:05:27","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/prometrika-announces-expanded-strategic-regulatory-consulting-services\/"},"modified":"2023-03-01T17:05:27","modified_gmt":"2023-03-01T16:05:27","slug":"prometrika-announces-expanded-strategic-regulatory-consulting-services","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/prometrika-announces-expanded-strategic-regulatory-consulting-services\/","title":{"rendered":"PROMETRIKA Announces Expanded Strategic Regulatory Consulting Services"},"content":{"rendered":"
\n

CAMBRIDGE, Mass.–(BUSINESS WIRE)–PROMETRIKA, LLC has announced that it has expanded its strategic regulatory consulting services under the leadership of Aileen Ryan, MS, Senior Regulatory Advisor, who has been providing regulatory consulting services to PROMETRIKA\u2019s client companies on a part-time basis for the past 2 years has now joined the company on a full-time basis. Ms. Ryan brings to this position over 40 years of diverse experience in pharmaceutical regulatory affairs, including regulatory strategy, submission preparation (IND\/NDA\/BLA\/MAA), and health authority interactions. Her experience spans submissions in the US, Canada, EU, and Japan. Other leadership roles have included supervision of clinical quality assurance, medical writing, and safety functions.\n<\/p>\n

<\/a><\/p>\n

\nAt PROMETRIKA, Ms. Ryan will spearhead regulatory affairs activities and will be available to provide its sponsors with strategic consulting and regulatory support from the pre-IND phase through marketing application preparation and approval, and continuing with life-cycle management. Ms. Ryan will also be providing the regulatory perspective to PROMETRIKA\u2019s Clinical Operations, Pharmacovigilance, Biostatistics, and Medical Writing functions, which will further enhance PROMETRIKA\u2019s delivery of best-in-class services.\n<\/p>\n

\n\u201cAileen\u2019s experience and approach are a natural fit for our company,\u201d commented Miganush Stepanians, President & CEO. \u201cAs a leader in regulatory affairs, she has always excelled at translating business and scientific objectives by providing regulatory support and guidance to clinical plans, ensuring high levels of quality and efficiency. This approach is one of the many reasons I am excited to have her join our leadership team.\u201d\n<\/p>\n

\nPrior to joining PROMETRIKA, Ms. Ryan\u2019s leadership roles have included Head of Regulatory Affairs and Compliance at the Ludwig Institute for Cancer Research, Vice President of Regulatory Affairs at Allos Therapeutics, Ophtherion, and Vion Pharmaceuticals, and Head of Global Regulatory Strategy for Oncology at Bayer Pharmaceuticals. Her work has covered drugs, biologics, and devices across a wide range of therapeutic areas. Recent areas of focus have centered on oncology, particularly early phase studies of immunotherapy treatments.\n<\/p>\n

\n\u201cI am eager to bring my years of experience to PROMETRIKA and its clients,\u201d said Ms. Ryan \u201cI am equally as enthusiastic to be part of an organization that sees the value in a collaborative team approach to clinical trials, and look forward to working with the entire team.\u201d\n<\/p>\n

\nMs. Ryan received her Bachelor of Science degree in Biochemistry from the University Massachusetts at Amherst and a Master\u2019s of Science in Basic Medical Sciences from New York Medical College.\n<\/p>\n

\nAbout PROMETRIKA, LLC<\/b> – www.prometrika.com<\/a>\n<\/p>\n

\nFounded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique Clinical Research Organization (CRO), utilizing a collaborative approach to clinical development and execution with a close\u2011knit, highly\u2011experienced senior leadership team involved in all phases of trials. PROMETRIKA\u2019s services include complete clinical operations and clinical trial management, data management, pharmacovigilance, biostatistics and programming, medical writing, and regulatory submissions.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nKathy Zheng
\n
617.844.0264
\n
kzheng@prometrika.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

CAMBRIDGE, Mass.–(BUSINESS WIRE)–PROMETRIKA, LLC has announced that it has expanded its strategic regulatory consulting services under the leadership of Aileen Ryan, MS, Senior Regulatory Advisor, who has been providing regulatory consulting services to PROMETRIKA\u2019s client companies on a part-time basis for the past 2 years has now joined the company on a full-time basis. Ms. … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-54393","6":"format-standard","7":"category-industry"},"yoast_head":"\nPROMETRIKA Announces Expanded Strategic Regulatory Consulting Services - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/prometrika-announces-expanded-strategic-regulatory-consulting-services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PROMETRIKA Announces Expanded Strategic Regulatory Consulting Services - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"CAMBRIDGE, Mass.–(BUSINESS WIRE)–PROMETRIKA, LLC has announced that it has expanded its strategic regulatory consulting services under the leadership of Aileen Ryan, MS, Senior Regulatory Advisor, who has been providing regulatory consulting services to PROMETRIKA\u2019s client companies on a part-time basis for the past 2 years has now joined the company on a full-time basis. 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