Tag Americas Announces Dr. Sharayu Maknikar, Director of Regulatory Affairs
Medical professional and regulatory specialist will oversee Regulatory Center of Excellence
NEW YORK, Feb. 15, 2023 /PRNewswire/ -- Tag, the global creative production partner to brands worldwide, announces the appointment of Dr. Sharayu Maknikar as Director of Regulatory Affairs for Tag Americas' Regulatory Center of Excellence.
The Regulatory Center of Excellence is a centralized team of medical, legal, and regulatory (MLR) subject matter experts assembled to substantiate and contextualize promotional pharmaceutical materials within the approval process. This team of experts allows pharmaceutical clients and production partners to remain focused on their day-to-day tasks while experts guide the materials through the workflow.
"Sharayu brings experience in medical practice, medical editing, and MLR operations," explains George Rex, Chief Operations Officer, Americas. "This valuable combination of clinical and regulatory expertise allows her to effectively help clients navigate the path to MLR approval. The MLR process is a critical step in a pharmaceutical brand's go-to-market execution."
Sharayu is certified in India as an Emergency Medicine Officer with experience in emergency medicine, critical care, and general medicine. Most recently, she was Manager of Regulatory Operations for Tag's MLR Center of Excellence in India, overseeing the team of regulatory specialists, medical editors, and traffic coordinators. This included the development, implementation, and ongoing maintenance and refinement of quality standard operating procedures.
"Joining Tag Americas' Regulatory Center of Excellence, I look forward to applying my medical knowledge to provide pharmaceutical clients with an extra level of assurance they may not get from other creative production partners—assurance that their marketing materials receive thorough medical review before submission to avoid issues that could delay MLR approval," says Sharayu. "More than ever, accuracy and speed to market is key to success."
Tag's Regulatory Center of Excellence helps pharmaceutical brands move regulatory and compliance considerations further upstream to help eliminate unexpected barriers to approval prior to review. This drives efficiencies and quality, leading to fewer review cycles and resulting cost savings. Learn more about what we do.
SOURCE Tag Worldwide (USA) Inc.
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