Gladys Martin
Written by Administrator
Thursday, 13 May 2010 03:42
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Gladys has 16 years of experience in Regulatory Affairs, prior to that she was a research polymer chemist in the medical device field. She has now turned her Regulatory expertise toward consulting with Pharma Consulting Solutions and provides consulting services to emerging companies. She specializes in regulatory requirements pertaining to labeling, advertising, and promotional materials from pre-approval stage through product launches and post-marketing support. She has extensive expertise in the process of labeling development, review, approval, and disposition of pharmaceutical (Rx, generics, and OTC) and dietary supplement products for domestic and international markets. This extends to approval of clinical trial labeling, submissions of the labeling sections for Annual Reports, Periodic Safety Update Reports, and advertising submissions to FDA. She has extensive experience acquiring US state licenses and registrations, and submission and maintenance of drug listings needed for commercializing drug products. She also has developed stock processes and tools for maintenance and renewal of state and federal licenses for facilities in the US and Europe.

Gladys' management focus has been in evaluating corporate needs and planning department staffing to meet those needs. This includes workforce analysis, job descriptions, screening candidates and salary negotiation. She has organizational strengths that work well in simplifying development of compliant regulatory processes and procedures. She is experienced in providing regulatory due diligence for the acquisition of new products. She has served as a regulatory reviewer on steering committees for the review and approval of advertising and promotions for Rx, OTC and dietary supplement products; has developed specialized databases to track advertising and promotional materials through the approval process and to the FDA. She has experience in regulatory document management.

Gladys is fluent in English and Spanish and has worked with Central and South American personnel to develop labeling for products crossing the US border.