We are sector experts
of REGULATORY AFFAIRS
Ensure the most efficient and streamlined path to approval in partnership with DMH Group regulatory and operational leaders.
We work side by side with your team and are attentive to your objectives , operational preferences and communication needs to customize your study design and regulatory strategy.
DMH is a reference in REGULATORY AFFAIRS
Scope for Medical Devices, Medicines, Food, Cosmetics, Sanitizers, Food Supplements and Medicinal Cannabis.
DMH Group offers a complete service from company regularization , audits , techno-surveillance , to pre-market, post-approval and post-market device testing management, including regulatory development, planning and submission support.
PERFORMANCE
• Regularization of companies (Operating License/Health Permit, Operating Authorization – AFE and AE, Certificate of Regularity, Certificate of Good Manufacturing Practices – CBPF and Certificate of Good Distribution and/or Storage Practices – CBPDA);
• Regularization of products subject to health control;
• Regulatory feasibility analysis of new products or maintenance of product registration status;
• Registration and notification of products with ANVISA and MAPA;
• Product registration and notification with the FDA;
- FDA 510(k)
• Registration and notification of products with the CE;
- CE MDR Classes I IIa, IIb and III
• Sending information to the contractor regarding publications related to the DOU , published legislation, representation at meetings at ANVISA;
• Regulatory Audit with risk assessment , creation of action plans and mitigation of regulatory requirements;
• Health legislation and technical regulations (training and impact analysis);
• Technovigilance notifications with ANVISA;
• INMETRO product certification ;
• Advice and consultancy for company certification with INMETRO .
• International Audits, focus on GMP.
NVISA
FDA
WHO
BENEFITS
To optimize your results and mitigate regulatory risks , we have a highly qualified team with more than 20 years of experience.
Do you want to achieve your business’ regulatory objectives and strategies ?
Development of regulatory strategy and paths to market
Consulting and support services throughout the product lifecycle
Preliminary assessments, gap analyzes and audits