The Indian Pharmaceutical and Medical Device consultancy market is seeing a massive shift with the introduction of various regulations and amendments to the existing ones like the Indian Medical Devices Rules 2017, European Union Medical Device Regulations 2017, Indian Cosmetic Rules 2020, and the soon-to-be revamped Drugs and Cosmetic Act. The new regulations are paving the way for a structured and effective regulatory network that will aid the Indian Medical devices & Diagnostics industry in keeping-up with the global regulatory and quality requirements.
With the deadline for transitioning into Indian Medical Devices Rules, 2017 fast approaching, manufacturers are rushing to implement systems with respect to quality management, facility requirements, and technical documentation. IQZYME MEDTECH Pvt. Ltd., founded in 2020, is a medical technology and quality consulting firm enabling companies to fulfill regulatory compliance by providing 360-degree services.
A Gamut Of Services
“At IQZYME, we place ourselves as a quality partner with an aim to educate and support our clients in implementing quality management systems and procedures”, says Sinto Poulose, CoFounder, IQZYME MEDTECH. Regulation, Quality Assurance, and Compliance require a high level of technical documentation, which is a big problem area for manufacturers. IQZYME houses an experienced and dedicated team focusing on technical documentation for a wide array of drugs, cosmetics, active & non-active medical devices, diagnostics, surgical products, and medical disposables.
Providing constant support to their clients through every stage of product development, identification of testing requirements & standards, literature search, technical drafting, patents, trademarks filing, support for the filing of import & domestic licenses, and product registrations in other countries especially CE certifications, UKCA and
USFDA registrations and licensing, IQZYME is a client-oriented, fullservice consulting firm.
Further, the firm provides customized and economical solutions to all clients, starting with the conduction of a gap analysis and focusing on all areas including facility design, qualification, Quality certifications of facility, R&D, product testing, product and process validations, clinical evaluations to post-market surveillance activities. Post analysis, the execution of suitable strategies includes clean room construction & validation, formulating SOPs, active onsite trainings, and technical documentation related to CDSCO, CE & USFDA licenses and ISO-13485 implementation.
They extend their trademark, patent, and technology transfer services to manufacturing companies, startups, and research institutes. In addition, as per the new regulatory norms, IQZYME also empowers its clients to be ready for any unannounced audits. “We take into account the unique characteristics of our client, their strengths and weaknesses, and offer optimized solutions”, adds Sinto.
Selma S, Director
Future Goals
“IQZYME’s vision is to be a leading global consulting company providing quality assurance and technology consultation that catalyzes our customers’ quest for better quality, compliance, and innovation. IQZYME is not a mere consultant, but is a quality partner to all its clients. IQZYME catalyzes clients’ needs related to quality, innovation, and compliance”, adds Sinto. In the fulfillment of this vision, the firm has laid-down a set of specific goals for itself.
We take into account the unique characteristics of our client, their strengths and weaknesses, and offer optimized solutions
By 2025, IQZYME aims to become an established player in the global medical device consultancy market. They are also working to venture into expanding the export of services to more countries, including the Middle-East and Europe. Constantly striving to be a part of the new regulatory process by upgrading their clients to newer standards and regulations, IQZYME is aiming to become a source of benefit for the common people who are the ultimate beneficiaries as the quality of products improves.
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