Medical devices consultant Services

About us?

Operon Strategist is a technical consultancy & regulatory advisory company providing consultancy ; guidance to various manufacturers in the healthcare industry to ensure strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide 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 timeline and to the highest quality standards in order to exceed expectations.

Operon Strategist is owned and 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 rising awareness among people of various healthcare options & people being more open to spend on quality healthcare services. To ensure that safe and 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 project
  • Timely execution of project deliverables
  • Assured confidentiality
  • Technically competent staff
  • Strong global presence Thorough knowledge of current market scenario & latest guidelines

Vision & Mission

 

Goal

We are Medical Device Turnkey project & Regulatory Consultant.our team qualified and experienced in Medical Device, Primary packaging, Cosmetics, regulatory practice, working across the America, Europe, Middle East and Asia-Pacific. Despite the reach and capabilities of our offices, we are large enough to guide fortune 50+ companies and small enough to guide individually owned companies, making us one of the most accepted regulatory specialists.

Vision

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

Mission

We are Medical Device Turnkey project & Regulatory Consultant.our team qualified and experienced in Medical Device, Primary packaging, Cosmetics, regulatory practice, working across the America, Europe, Middle East and Asia-Pacific. we are large enough to guide fortune 50+ companies , making us one of the most accepted regulatory specialists.

Panel Experts/Advisors

Anand-1

Anand Akerkar, Ph.D.

Dr. Akerkar has over 45 years of experience in the healthcare industry. Anand held several senior management positions at Ciba Giegy, Becton Dickinson, and Technicon Corporation. Dr. Akerkar has successfully managed the development, launch and management of in-vitro diagonostic 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

Alan Schwartz

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.

Our Partners