Operon Strategist is a technical consultancy & regulatory advisory company providing consultancy & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide a complete turnkey solution to manufacturers looking to set up a world-class manufacturing unit. We also provide customized packages as per the requirements of the client. Our global presence caters to clients from around the globe & includes small start-ups to world’s renowned medical device manufacturers. We have a team of experts whose knowledge & experience helps them handle clients both small & large. As a trusted partner to our clients, we strive to provide services within budget, agreed on timeline & to the highest quality standards in order to exceed expectations.

Operon Strategist is owned & partnered with world’s competent companies & renowned personalities in the field of regulatory consulting. With more than 60+ cumulative years of experience, providing 1000+ services in the field of regulatory consulting, Operon Strategist’s strategic alliance with these companies helps clients in obtaining an insight into the regulations of various countries.

Healthcare industry is steadily growing both in India as well as internationally which can be attributed to raising awareness among people of various healthcare options & people being more open to spending on quality healthcare services. To ensure that safe & effective products reach the end consumer, manufacturers must ensure that they have an efficient manufacturing unit site equipped with a well-organized quality system & skilled workforce. Operon Strategist guides such manufacturers in various aspects of regulatory requirements.

Why choose us?

  • Commitment, responsibility & liability during & after completion of the project
  • Timely execution of project deliverables
  • Assured confidentiality
  • Technically competent staff
  • Strong global presence Thorough knowledge of current market scenario & latest guidelines.

Vision & Mission

Operon Strategist aims to provide regulatory consultancy services to healthcare industries to ensure a high level of compliance with the good quality product. We do this by following ethical approach, well-grounded training & services with complete experience and expertise to meet the clients need for quality, consistency and time bound services.

Panel Experts/Advisors

Anand Akerkar, Ph.D.

Anand-1

Dr. Akerkar has over 45 years of experience in the healthcare industry. Anand held several senior management positions at Ciba Giegy, Becton Dickinson, and Technical Corporation. Dr. Akerkar has successfully managed the development, launch, and management of in-vitro diagnostic products. While at Becton Dickinson, he was a member of the industry review board for the FDA that helped to define the 510(K) submission requirements and other clinical chemistry standards. Dr. Akerkar holds 11 patents and has been published over 150 times in recognized scientific journals. Dr. Akerkar has been a consultant to the healthcare industry since 1986. Dr. Akerkar was the Scientific Advisor to ex-U.S. Congressman Benjamin Gilman.

Alan Schwartz

Alan

Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations.

Partners & Associates

  • Tyone, Nenagh Co. Tipperary, Ireland
    Tyone, Nenagh Co. Tipperary, Ireland
  • P O Box 6179, Point Cook VIC 3030, Australia
    P O Box 6179, Point Cook VIC 3030, Australia
  • Room 1103, Yu Fei building No. 42 Dong Zhi Men Wai Street, Dong Cheng District Beijing, P.R. China
    Room 1103, Yu Fei building No. 42 Dong Zhi Men Wai Street, Dong Cheng District Beijing, P.R. China
  • Rua Batataes, 376-Jd. Paulista CEP 01423-010, Sao Paulo, Brasil
    Rua Batataes, 376-Jd. Paulista CEP 01423-010, Sao Paulo, Brasil
  • 55 Northern Blvd, Great Neck New York 11021, United States of America
    55 Northern Blvd, Great Neck New York 11021, United States of America