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Profile of Expert On Medical Devices
Technically competent to implement project right from Project planning, monitoring, and execution with
technical knowhow and hands on experience having worked with major organizations in setting up
manufacturing facilities for Medical device in India and abroad as well.
Professional exposure of more than two decades in setting up multifunctional domains with highly reputed
business establishments - specialized skills in project management, production management, productivity &
process improvements, manufacturing planning & controal, sourcing & procurement, techno-commercial
operations, technology integration, and QMS implementation in the field of Medical devices. And “Internal
Auditors” for ISO 13485:2016 (QMS-MEDICAL DEVICES) ISO 19011:2018 Guidelines for audit management.
Individually handling and setting up whole projects of Plastic molding and allied machines for producing
range of medical devices in these segments:
Expertise of various plastic processing line like Injection Molding and Extrusion Process and their packaging.
Also, for maintenance of production lines, and managing logistics to achieve unit's production and
profitability objectives
Implementing measures for wastage control, cost rationalization, and increased productivity; abilities in
routinely meeting production schedules while holding production costs in check, bringing about significant
reductions and deploying process improvement strategies.
Implementing occupational health & safety, ISO, CE and WHO-GMP, PQS (WHO) standards; expert in
implementing Good Manufacturing Practices, conceptualizing and effecting process initiatives, 5S to
enhance efficiency.
Profile Of Other Panelists
We have experts with a wide range of expertise in pharmaceutical industry who are empanelled with us who
will ensure the right layout in terms of GMP compliance to international regulations, selecting right
machineries, validations and handholding initial operations till approval by USFDA authorities.
One of our experts in the panel has an experience of almost 3 decades in the pharmaceutical industry and
has worked in senior management positions and has experience of heading greenfield and brownfield
projects which eventually were approved by USFDA and are doing very well in the US market today. We have
people highly specialised in sterile project and operations who have a good track record and recently
executed a most USFDA compliant approved facility.
Our panel of experts comprise of people who have held senior positions in cross functions and have led from
the front, and hence the compliance and operating efficiency will be built into the facility design, major
machineries and processes, most of all, with a very high level of transparency, honesty and integrity which is
a rare commodity in current times in project consultants.
