Celegence: Effectively Improving Regulatory Operations for Medical Device Manufacturers
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Sonia Veluchamy, Co-Founder & CEO
Compliance isn’t easy. That’s a reality that life sciences companies have long understood, and it’s one that medical devices companies are now grappling with. The new European Medical Device Regulation (MDR), Unique Device Identification (UDI) system, Medical Device Single Audit Program (MDSAP), other more regional harmonization initiatives, create new challenges for companies, which are hindered by the inability of their systems and processes to quickly adjust to changing requirements. These regulatory requirements and initiatives are also accelerated through organizations like International Medical Device Regulators Forum (IMDRF) focused on medical device regulatory harmonization and convergence. Manufacturers are finding these changes as a burden in some cases, and this can be attributed to the lack the transparency and control needed to comply with regulations.
Celegence understands the challenges medical devices companies face and combines its services with its solutions to provide a holistic approach to managing compliance. “With a depth of regulatory expertise and an extensive global delivery capability, we help companies strategize, proactively plan, and implement local and global regulatory requirements,” says Sonia Veluchamy, CEO & Co-Founder of Celegence. “Celegence specializes in helping clients reduce time to market and cost related to lifecycle management of medical devices from a regulatory affairs perspective by providing information-based services.”
For now, the main focus for medical device manufacturers is the European MDR, which comes into full effect in May 2020, replacing the three existing medical device directives (93/42/ EEC, 98/79/EC and 90/385/EEC). The EU MDR places additional pressure on regulatory, quality, and clinical departments as it requires manufacturers to plan pro-actively to gather, record, and analyze performance and safety data throughout the lifecycle of medical devices placed on the market. “Manufacturers are struggling to adapt their processes, systems, and core skills of personnel in order to meet changing production demands of speed, flexibility, and safety while complying with regulations,” Sonia says.
Founded in 2017, Celegence provides expert medical device regulatory consulting for each step of the medical device product lifecycle and across a complex global regulatory terrain.
With a depth of regulatory expertise and an extensive global delivery capability, we help companies interpret and meet global and country-specific requirements
Celegence’s team of regulatory specialists deliver expertise on implementing systems and processes for medical device design and development, manufacturing, and post-market surveillance for technical file compliance with the new MDR regulation, and can help customers to create and remediate technical product files. The company assists its customers in the areas of regulatory intelligence, medical writing, Regulatory Information Management (RIM), publishing, labeling, and compliance toward new regulations for different product portfolios. “With our solutions and services, we offer companies clear visibility and control over their diverse product portfolios, increased operational efficiency, lowered cost, and ongoing regulatory compliance,” Sonia says.
Celegence works across all phases of the product lifecycle, from regulatory strategy and planning to all aspects of established product maintenance— including content creation or update, submission management, publishing, and health authority interaction. To assist companies with knowledge management as well as interpretation of local and regional regulations, Celegence has established a unique solution, the Simplified Regulatory Intelligence (SRI) Platform, which helps companies to devise the right regulatory strategy for maintaining and launching products globally based on expert global regulatory insights.
Moreover, the company leverages a global team of consultants to offer local regulatory insight, strategy, and intelligence. “With our team of medical regulatory experts, we develop the optimal regulatory strategy, which depends on the device and market targeted by the customer,” Sonia says. “With more than 25 years of combined experience in the life sciences industry and over 15 years in regulatory affairs to draw on, our regulatory consultants apply up-to-date, robust regulatory intelligence to support overall product development and maintenance strategies.” Due to its high-quality service and niche subject matter expertise, Celegence has been garnering massive traction in the market. But Celegence won’t be resting on its laurels and is continually investing in talent and technology research & development to support life sciences companies as market requirements and regulations continue to adapt. “Our deep knowledge of regulations and processes allows us to speed up the medical device registration, submission process, and adherence to new compliance requirements,” Sonia adds. “We will continue to work with our customers to optimize their processes and ensure that they can take advantage of efficiency gains, whether it be through evolving their processes or leveraging our technology.”
Description The company assists life sciences companies navigate complex global regulatory requirements by providing expert consulting services and solutions dedicated to regulatory affairs. It offers high-quality medical device regulatory consulting for each step of the product lifecycle. The company assists its customers in the areas of regulatory intelligence, medical writing, RIMS, publishing, labeling, and compliance with new regulations for different product portfolios. Celegence works across all phases of the product lifecycle, from regulatory strategy, authoring, to all aspects of product maintenance, including submission management, publishing, and health authority interaction
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