In an ever-evolving world of diseases and patient needs, it is important to find the right market for product execution and vice versa. It is also necessary to apply right strategy aligning with country specific regulatory framework. In order to stay ahead, companies leverage consulting firms that advise them at all stages of product life cycle.
MakroCare is a leading consulting firm with a focus on BioPharma and Medical Devices industries. It specializes in Advisory, Clinical/Medical, Regulatory Affairs, and Product Support areas. Its global experience, process accelerators, and proprietary technology bring a new dimension to client’s product development, life cycle management, and compliance areas. The company has its operations and presence in the US, UK, EU, and Asia. It is positioned to meet the demands of the expanding product portfolio needs of clients worldwide. With several business models and services, MakroCare offers different options to clients either for full-service or functional areas.
Focused Services
Established in 1996, it took several years for the company to prove its competency and credibility. It took its own time to get to larger customers by increasing its branding and constantly introducing new services to match changing needs of the industry. MakroCare’s current services are focused on BioPharma, and Medical Devices & Diagnostics.
BioPharma: For BioPharma, focus areas include Regulatory Services, Clinical Research, Biometrics, RWD and Automation.
Medical Devices & Diagnostics: For MD&D, focus areas include Regulatory Affairs, Risk Management, Compliance, Clinical Evidence, PMCF, PMS and Product Complaints.
An Experienced Leader
Mahesh Malneedi is a Co-Founder and the President of MakroCare. He has been instrumental in the growth of MakroCare and placing it among the fastest growing Clinical Research Organisation. His twenty years of business experience is a valuable asset to MakroCare as it races ahead with a mission of accelerating new medicine and devices developed in the industry while focused on company and employees growth in parallel.
Humanitarian Aspect
Makro Foundation is a non-profit organization run by the company. The foundation primarily focuses on Prevention of Deaths due to Avoidable Mishaps, through education and counseling.
It provides emotional support, counseling and guidance to all psychological, emotional and behavioral problems of an individual. It combines modern psychological therapies to help individuals resolve their concerns. It believes in the holistic health definition of the World Health Organization which is a complete state of physical, mental, and social well-being, and not merely the absence of disease or infirmity.
Quality and Awards
Quality Assurance (QA) is an intrinsic part of MakroCare’s process and projects. Its global QA team has highly qualified and experienced auditors with expertise on national and international regulations and guidelines. The QA department brings strong experience to achieve customer satisfaction and deliver the highest quality standard for all its services. Its facility is certified with ISO: 9001(QMS), ISO: 27001(ISMS) and ISO: 14155 (Medical Device Clinical Investigations). Its contribution to the industry has been recognised at several platforms and the company has received the following awards:
- AI Business Excellence Award – Best Bio-Pharma Development Partner
- TOPRA Award for Excellence in Regulatory Communications 2013
- 3 times INC 5000 Company
With these awards already in its kitty, the company is bound to continue its amazing work and is aiming to be in TOP 3 in the industry for a few specialized areas in Medical Devices and BioPharma.
