Syntacog
Syntacog is a company dedicated to simplifying regulation and compliance for businesses through innovative software and expert support. They offer the Regtik platform, a patent-pending regulatory affairs tool that helps manage compliance obligations efficiently, reducing time and effort while minimizing errors and penalties. Their services span medical devices, COVID-19 travel restrictions, health and safety, and regulatory consulting, aiming to accelerate market access and ensure regulatory compliance.
Industries
Nr. of Employees
small (1-50)
Syntacog
Products
Regulatory compliance software platform (patent-pending)
A platform that provides guided assessments for product qualification and classification, regulatory pathway mapping, automated regulatory intelligence, and generates documentation to support regulatory planning and submissions.
Regulatory compliance software platform (patent-pending)
A platform that provides guided assessments for product qualification and classification, regulatory pathway mapping, automated regulatory intelligence, and generates documentation to support regulatory planning and submissions.
Services
Consultancy to plan and implement regulatory strategies, prepare regulatory documentation, and advise on standards and quality management system implementation. Delivered by an internal team and a network of external experts.
Consultancy to plan and implement regulatory strategies, prepare regulatory documentation, and advise on standards and quality management system implementation. Delivered by an internal team and a network of external experts.
Expertise Areas
- Regulatory compliance for medical devices
- Medical device qualification and classification
- Regulatory strategy and pathway selection for global markets
- Quality management system and standards implementation (ISO 13485, ISO 14971, IEC 62304)
Key Technologies
- Regulatory compliance software
- Expert system for regulatory decision support
- Automated regulatory intelligence / monitoring
- Guided regulatory assessment workflows
News & Updates
Syntacog provides a platform to understand and navigate the complex regulatory environment for medical devices, helping companies bring innovative products to market faster.
Syntacog offers guidance on travel restrictions related to COVID-19, simplifying the process for businesses and individuals.
Syntacog provides a platform to understand and navigate the complex regulatory environment for medical devices, helping companies bring innovative products to market faster.
Syntacog offers guidance on travel restrictions related to COVID-19, simplifying the process for businesses and individuals.