Regulatory Compliance: Guiding Your Botanical Products to Market with Confidence
Bringing plant-based wellness products to market demands expert navigation of evolving regulatory landscapes. At Botanic Biosciences, our specialized Regulatory Compliance team provides comprehensive, end-to-end support to ensure your formulations meet all necessary standards—from new product launches to updates on existing lines. We help brands stay compliant, competitive, and focused on innovation in the fast-growing botanical and nutraceutical space.
Comprehensive Regulatory Support Services Include
- Full cGMP Compliance Guidance — Alignment with current Good Manufacturing Practices (21 CFR Part 111) for dietary supplements
- Documentation and Submission Preparation — Master manufacturing records (MMRs), certificates of analysis, and all required regulatory documentation
- OTC Drug Manufacturing Expertise — Full facility approval and support for Over-the-Counter products
- Labeling and Claims Review — Ensuring truthful, non-misleading claims compliant with FDA guidelines (including structure/function claims)
- Regulatory Strategy for Product Launches — Proactive planning for new formulations, ingredient sourcing, and market entry
- Ongoing Compliance Monitoring — Staying ahead of regulatory changes, audits, and updates affecting botanical extracts, functional supplements, topicals, and ingestibles
Why Choose Botanic Biosciences for Regulatory Compliance?
- Proven experience navigating complex requirements for private label, white label, and custom botanical products
- cGMP-certified and OTC-approved facility in the USA
- End-to-end partnership that reduces time-to-market and compliance risks
- Trusted expertise in plant-based wellness, backed by scientific precision and nature-focused innovation
- Support for brands scaling from small batches to full production
In an industry where regulations evolve rapidly, our team combines deep regulatory knowledge with practical manufacturing insight to clear the path for your success. From initial concept to retail-ready product, we ensure your botanical innovations are compliant, safe, and market-ready—without sacrificing creativity or quality. Let’s ensure your next product launch is compliant and confident. Reach out to our experts at info@botanicbiosciences.com today.
