A Global Shift for Manufacturers: The International Demand for cGMP Compliance

A Global Shift for Manufacturers: The International Demand for cGMP Compliance

Meeting global demand while adhering to regional regulatory needs

The global cannabidiol market is poised to grow by $29.91 billion during 2021-2025, progressing at a CAGR of 26.93% during the forecast period.1 Europe, North America, Latin America, Asia Pacific, and the Middle East comprise the regions within the global CBD marketplace. So what does that mean for manufacturers? International regulators are becoming more favorable towards CBD and for manufacturers, meeting cGMP compliance is a requirement. In Australia, all current CBD products are to be manufactured compliant to a pharmaceutical process. Additionally, the international landscape has seen many Latin American governments taking steps to create legal markets for CBD products, however, companies must ​comply with extensive GMP requirements. As the cannabinoid industry matures, domestic and international regulations will define manufacturing and quality requirements, only allowing manufacturers who meet these regulations to market products. The CBD market within the outlined regions can be segmented into the following profiles: pharmaceuticals, natural health products/dietary supplements, cosmetics/topicals, and food and ingredients. In 2020, pharmaceuticals accounted for the highest revenue share of 42.8%.2 As clinical trials with CBD products continue to demonstrate value in areas of unmet medical need, Vantage Hemp Co. provides international partners with cGMP compliant APIs and clinical trial dosage formats to support their pursuit of regulatory approvals. Companies that look to meet global manufacturing demand have a requirement to be regulatory compliant across all regions of interest. The international pharmaceutical industry demands cGMP compliance to partner with a manufacturer. Equally, the natural health/dietary supplements, cosmetics and food and ingredients segments look for a manufacturing partner who understands the unique differences for each region they sell products into. Today, a “one size fits all” manufacturing approach is no longer relevant or acceptable. International clients are requiring compliance, greater variation in products, competitive manufacturing cost, delivery reliability, and more types of after-sales service—requirements Vantage consistently meets. “We believe Vantage has what it takes to go global and we’ve taken a metered, strategic approach to execution. We’re prepared to overcome challenges and aren’t afraid to move forward and move forward quickly,” said Christian Santi, Director of Sales at Vantage. “When you expand globally, each country you reach comes with a new set of regulations,” added Santi. “What works in your home country may not work in another.”   1 https://www.researchandmarkets.com/reports/5510825/global-cbd-market-2021-2025?utm_source=GNOM&utm_medium=PressRelease&utm_code=xq3s7r&utm_campaign=1639800+-+Worldwide+CBD+Industry+to+2025+-+Rising+Popularity+of+CBD+Oil+is+Driving+Growth&utm_exec=jamu273prd 2 https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market

Laura Eder

Laura Eder has more than 19 years of experience in the life-cycle management of pharmaceuticals and medical devices. She has had her Regulatory Affairs Certificate (RAC) since 2012. Through her time spent in the world of pharmaceuticals, she has developed a comprehensive knowledge and understanding of FDA regulations, as well as worldwide regulations. She has created an outstanding relationship with the FDA's Office of Prescription Drug Promotion (ODPD) for over 15 years submitting websites, commercials, and promotion materials without issue. Early in 2019, she transitioned into the CBD industry as the Regulatory Manager where she helped to guide the company through several significant regulatory milestones. Leading a team to complete ISO 9001:2015, as well as GMP 111 (dietary supplements) and 117 (food) certifications in record time. The audits with SGS were completed in just three months due to her leadership skills, experience and understanding of what would be needed for this industry. Following that Laura started her own consulting business for a short period before joining Vantage. Once she saw the opportunity at Vantage where she could use her pharmaceutical knowledge and experience in the CBD industry she knew it was the perfect relationship. Since being at Vantage Laura has again completed another successful audit. The annual surveillance audit this past February 2022 which was conducted by SGS at the pharmaceutical level and no findings was the final outcome. Laura is looking forward to moving the CBD industry forward ethically and legitimately with transparency to government agencies such as the FDA.

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