A Little About Us
Regulatory affairs play a vital role in making healthcare innovation accessible to patients and to ensure that product stays in the market with continued compliance with regulatory requirements through-out the product life-cycle. InnoReg Solutions is a Regulatory Consultancy, specialized in providing high-quality, compliant and cost-effective regulatory solutions to our clients amidst the complex and dynamic regulatory environment.
As the name “InnoReg” suggests, it is a thoughtful blend of “INNOvation” and “REGulatory”, primarily focused on Medical Device industry known for short product lifecycle and bringing innovations to the market at fast pace. Our regulatory expertise spans all risk-class devices and diverse product portfolio marketed in India. We can support the regulatory needs of companies of every size in medical device sector (large, medium and small size companies), as your trusted regulatory partner. We are specialized in regulatory services ranging from India device registration process, guidance on regulatory strategy, dossier compilation, post-approval changes, product portfolio analysis for regulatory requirements, regulatory intelligence updates, training on new regulations and other related regulatory activities regarding medical devices.
Regulatory Services Offered by InnoReg Solutions
Medical Device
Registration Process
In addition to regulatory strategy, we can assist you with device registration process in India including risk classification, gap analysis, dossier compilation, submission to authorities and response to queries raised by authorities.
Regulatory
Intelligence Updates
Regulatory environment is changing fast with major developments happening in short period of
time. We can partner with you to provide regular updates on regulatory environment or resolve your specific queries on different aspects of regulation. We can also support you with impact assessment of regulation changes specific to your product portfolio & assist you in developing compliance mapping products.
Our Team
Mamta Makkar is the Chief Regulatory Consultant at InnoReg Solutions based in New Delhi, India. Armed with rich experience in Global Companies like Edwards Lifesciences, Medtronic, Johnson & Johnson and Biogen Idec, she has extensive industry experience in leading various regulatory projects, registration process and system development in dynamic regulatory environment. Prior to InnoReg assignment, she was heading the Regulatory Function at Edwards Lifesciences while being part of Company’s India leadership. In 2021, she envisioned the opportunity of providing high quality regulatory services to support healthcare companies with compliant and cost-effective regulatory strategies under the platform of InnoReg Solutions.
She has in-depth experience spanning multiple aspects of medical device regulations like end-to-end registration process, license lifecycle management for product changes, labelling compliance, regulatory intelligence updates, spearhead the project of registering nonregulated devices and devising regulatory strategy in alignment with organization goals. She also has vast experience in supervising and mentoring the industry regulatory professionals as in-house functional head or as part of strategic regulatory partnership with the Medical Device Companies. She holds a Bachelor’s degree in Pharmacy (B. Pharma) and Master’s degree in Quality Assurance (M. Pharma - QA) from Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi.
InnoReg is also supported by network of highly knowledgeable consultants with immense experience in device registration process and understanding of the regulatory landscape.
Job Openings at InnoReg
We do not have job openings currently. We will post openings as & when we have the requirement in future.
