KGK Compliance Advisors offers regulatory compliance assistance to manufacturers, suppliers and distributors in the natural health product industries. We can assist you in meeting the demanding and sometimes overwhelming regulatory requirements of the nutraceutical industry – from ongoing expert advice and assistance to outsourced compliance staffing needs. Our team has first-hand expertise in helping companies to achieve and maintain compliance for FDA, FTC and other regula-tory agencies and accomplish an overall successful outcome in product launches
Services offered by KGK Compliance Advisors include GMP training for all levels of a company, SOP review, and pre-audit services in preparation for third party certifications, basic label reviews, and a portfolio of services and training in the regulatory arena. Our team has expertise in manufacturing and production, GMP auditing, supply chain qualification, quality control optimization, label claims, guidance on regulatory operations and technical marketing for health and wellness products.
KGK Compliance Advisors offers a range of services to assist companies to become more compliant and efficient in their facilities, processes and procedures. Compliance Services provides “Best Practice” consulting and a phased approach for companies in their sales, marketing, operations, quality, R&D and facility areas.
Areas of support and services include:
- Pre-audits - facility and process audits in preparation for third party certifications, FDA issues or overall bench-marking of compliance status.
- Review of documentation, traceability, AER’s, process controls, MMR’s, MBR’s, testingrequirements and documentation.
- FDA Response Letters, CAPA Planning
- Optimization of Quality Assurance & Control - Regulatory Strategy Planning
- Quality Agreements for Laboratories, Manufacturers and Distributors
- Gap Analysis
- Compliance Operations - Planning & Implementation
- Facility Consulting for Processing and Manufacturing / Distribution
- Establishing Standard Operating Procedures (SOP’s)
- SOP Review and Change Control Systems
- Supplement Facts and Labeling
- Data Sheets - Creation and Verification
- Supplier Audits
- Product label review
- Supplier Training
- Consulting and Advisement