Consultation Services
At Briata Group, we specialize in providing expert guidance and support in Quality Systems and Regulatory compliance for American companies operating in the food, dietary supplements, and medical devices industries. With our deep expertise and comprehensive understanding of these sectors, we are dedicated to helping our clients navigate the complex landscape of quality assurance and regulatory requirements.
Quality Management System
Regulatory Compliance Support
Audits and Inspections:
Training and Education
People Placement
Regulations & Standards We Support
Regulation:
- FDA Food Safety
- Modernization Act (FSMA)
- Food Allergen Labeling
- Nutrition Labeling
Industry Standards:
- Hazard Analysis and Critical Control Points (HACCP)
- Good Agricultural Practices (GAP)
Certifiable Standards:
- ISO 22000:2018 (FSMS)
- FDA cGMPs for Food
- SQF Program
- BRC Global Standard for Food Safety
- IFS Food Standard
Regulations:
- Dietary Supplement Health and Education Act (DSHEA)
- Labeling Requirements
- New Dietary Ingredient (NDI) Notification
- cGMPs for Dietary Supplements
Certifiable Standards:
- NSF International’s GMP for Dietary
- Supplements (NSF/ANSI 173)
- UL’s Dietary Supplement Certification
Regulations:
- FDA Medical Device Regulation (21 CFR Part 820)
- Medical Device Reporting (MDR)
- Unique Device Identification (UDI) System
Industry Standards:
- International Electrotechnical Commission (IEC) 60601 (Medical electrical equipment)
Certifiable Standards:
- ISO 13485:2016 (QMS)
- CE Marking
- FDA’s Premarket Approval (PMA) Process
Our Unique Approach
Industry Expertise
Briata Group Consulting Services distinguishes itself through its profound understanding and practical experience within the food, dietary supplements, and medical devices sectors. This expertise allows the team to navigate the intricacies of these industries with finesse, providing clients with tailored solutions that address specific challenges.
Proven Track Record
With a history of successful engagements, Briata Group has established itself as a reliable partner for clients seeking to enhance quality and compliance standards. Through collaborative efforts and meticulous attention to detail, the consultancy has consistently delivered tangible results, earning trust and loyalty from a diverse clientele.
Client-Centric Approach
Briata Group places paramount importance on client satisfaction, infusing their consultancy services with a blend of industry expertise and an intimate understanding of client objectives. This ensures the delivery of tailored, practical solutions that not only meet compliance standards but also foster sustainable growth and success for the client's business endeavors.
