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.”