Who We Are

Our firm is here to advise and support you on a wide range of regulatory documentation and cGMP advisory solutions.


Our Mission

Our mission is to interpret and understand standard requirements,


Our Vision

To emerge as a leading regulatory consulting company by endorsements from existing satisfied customers

PLANNING

find new ways and build new strategies to overcome the possible questions from regulatory authorities.

Masacare co.

Masacare is a vibrant and customer-focused company that provides healthcare product manufacturers across the globe with US, EU & India medical device regulatory consultants services.

Masacare insists on honesty, integrity, and fairness in all aspects of our business and expects the same in its relationships with domestic and international customers. This has earned the trust and respect from our existing customers and is acknowledged as the best!


COMPANY OVERVIEW

Providing the Best Regulatory Solution withQuality Assurance & Data Security


“We care deeply about what we do and the impact we have with our clients and with the communities in which we work and live. It is personal to all of us.”  Our Core values shape the culture of our organization and define the character of our company


Masacare a sustainability partner for leading corporate, medium and small scale healthcare product manufacturers across the world. Headquartered in Bangalore, India, we are the Asia Pacific region’s largest regulatory service provider for USFDA, EUMDR / IVDR and INDIA FDA Compliance for the Healthcare product manufactures. In the year 2000, Masacare started with the vision to become a sustainability partner of choice for “all” looking to launch healthcare products in the USA & EU from foreign countries. Masacare has the power of highly skilled and professional team spread across our offices in Germany, India and USA. The majority of new customers are referred to Masacare by existing customers and their employees. Here are kind words from a few of our satisfied customers about their experience with us during their journey to success.


Regulatory Documentation and Electronic Submissions to regulatory bodies – this process seems simple but it is a highly complex, resource-intensive and time-consuming task. It is always best to leave it to the experts at Masacare!


What is Special with Us and Why Our Clients Like Us?

Our strong technical team spread in three continents along with their commitments to core values has helped Masacare build long-term, value-centric relationships with customers and become one of the best and dependable global US FDA & EU Medical Device Regulatory Consultants.



EXPERIENCED TECHNICAL CONSULTANTS

We have the largest pool of full-time technical consultants. Any project can be started quickly.   

FAIR PRICE & ONTIME DELIVERY

Customers across the globe are attracted to us due to our fixed and fair pricing policy.            

DATA SECURITY & CLOUD DOCUMENTATION

ISO 2711 for data security. We work, and we deliver documents via the cloud with 24 x 7 uptime assurance.

MEDICAL DEVICES

CE Marking according to new Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).US FDA 510k clearance for medium risk and high-risk devices followed by device registration and listing.

DRUGS

US FDA controls the sale of drugs.All establishments have to register and list the drug products before the sale or import of such products to the United States of America.The registration is to be followed by Finished drug manufacturers, brand owners, API manufacturers, and drug testing laboratories.

FOOD/FOOD SUPPLEMENTS

The USA Bioterrorism Act directs FDA to take steps to protect the public from any
threats via the food supply.To carry out, the FDA enforces all manufacturers and importers to register their facilities involved in the supply chain.It also imposes us with the requirement to be given advance notice on shipments of imported food also known as prior notice.

COSMETICS

The Voluntary Cosmetic Registration Program, so-called VCRP regulation is made by the FDA for cosmetic manufacturers and brand owners. VCRP insists that all ingredients used for cosmetic products must be intimated to the FDA via a so-called system called ingredient statement filing.READ MORE

en_USEN