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Qual Conform’s dietary supplement experts develop winning strategies tailored to your products:
– Regulatory landscape assessments and gap analyses
– Ingredient safety and regulatory status evaluations
– Compliance strategy development for DSHEA and FDA regulations
– Risk assessment and mitigation planning
– Regulatory due diligence for mergers and acquisitions
Qual Conform guides you through the NDI notification process:
– NDI status determination and historical use assessment
– Safety data compilation and evaluation
– NDI dossier preparation and submission
– FDA communication and response management
– Post-submission strategy and market entry planning
Qual Conform supports your GRAS initiatives:
– GRAS eligibility assessment
– Scientific literature review and gap analysis
– Safety assessment and toxicology studies coordination
– GRAS panel selection and management
– GRAS notification preparation and submission to FDA
– Self-affirmed GRAS process support
Qual Conform ensures your claims are compliant and well-supported:
– Structure/function claim development and substantiation
– Health claim and qualified health claim assessment
– Scientific evidence evaluation and dossier preparation
– Claims notification to FDA
– Advertising and marketing material review
Qual Conform helps establish robust QMS aligned with FDA requirements:
– 21 CFR Part 111 (Dietary Supplement cGMPs) compliance
– Quality manual and standard operating procedure (SOP) development
– Hazard Analysis and Critical Control Points (HACCP) implementation
– Supplier qualification and management programs
– Employee training program development and implementation
Qual Conform ensures your manufacturing processes meet FDA standards:
– GMP gap assessments and remediation planning
– Manufacturing process optimization for GMP compliance
– Batch production and master manufacturing record development
– In-process control and finished product testing programs
– Stability testing program design and implementation
– Expiration date assignment and shelf-life studies
Qual Conform prepares you for regulatory scrutiny:
– Mock FDA inspections
– Third-party GMP certification audit preparation (e.g., NSF, UL, USP)
– Supplier audits and qualification
– FDA inspection readiness and support
– FDA 483 observation and Warning Letter response assistance
Qual Conform ensures your product labels meet all regulatory requirements:
– Supplement Facts panel development and review
– Ingredient listing and naming conventions guidance
– Allergen labeling and precautionary statements
– Nutrient content claim compliance
– Structure/function claim label integration
– Label design review for FDA compliance
Qual Conform provides expert guidance for complex labeling scenarios:
– Probiotic supplement labeling
– Botanical and herbal supplement labeling
– Sports nutrition product labeling
– Weight management supplement labeling
– Organic and natural product labeling claims
– International label adaptation for global markets
Qual Conform helps ensure your marketing materials are compliant:
– Website content review for regulatory compliance
– Social media and digital marketing guidance
– Print and broadcast advertising material assessment
– Product catalog and brochure review
– Trade show and promotional material evaluation
Qual Conform supports your post-market safety monitoring:
– Adverse event reporting system development
– Serious adverse event (SAE) reporting to FDA
– Pharmacovigilance program implementation
– Safety signal detection and evaluation
– Product recall strategy and management
Qual Conform assists in maintaining and improving compliance:
– Periodic GMP compliance assessments
– Quality system performance metrics development
– Continuous improvement program implementation
– Employee GMP refresher training
– Regulatory intelligence monitoring and impact analysis
Qual Conform ensures the quality and consistency of your products:
– Analytical method development and validation
– Identity testing program development for botanical ingredients
– Contaminant testing strategy (e.g., heavy metals, microbial, pesticides)
– Finished product specification development
– Laboratory audit and compliance support
Qual Conform streamlines your FDA registration process:
– Facility registration with FDA
– Product listing and annual updates
– Label submission to FDA
– U.S. Agent services for foreign manufacturers
Qual Conform facilitates your global business operations:
– Import alert monitoring and resolution
– Export certificate applications
– Customs and border protection compliance
– International regulatory requirements assessment for dietary supplements
Read more about Regulatory Support Service