Science-first Contract Development & Manufacturing Organization
Comprehensive guides, white papers, and training materials to support your product development journey. Access expert knowledge on regulatory compliance, market strategy, formulation science, and more.
Navigate complex regulatory frameworks with confidence. Our guides cover FDA compliance, international regulations, and best practices for OTC, supplements, cosmetics, and medical devices.
Complete guide to OTC drug monograph requirements, labeling standards, and submission processes.
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Master specifications, validation, and quality control requirements for dietary supplement manufacturing.
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Understanding the Modernization of Cosmetics Regulation Act requirements, facility registration, and PIF documentation.
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Quality management systems, design controls, and validation protocols for medical device manufacturing.
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ICH Q1A/B guidelines, storage conditions, and documentation requirements for stability programs.
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Compliant label formats for OTC drugs, supplements, and cosmetics with regulatory claim guidance.
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Build compelling product stories and effective go-to-market strategies. Learn how to position your products, craft compliant claims, and reach your target audience.
Strategic frameworks for differentiating your product in competitive markets.
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How to craft structure/function claims and marketing messages that meet regulatory standards.
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Successful direct-to-consumer launch approaches for emerging health brands.
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Templates for building consistent, compliant messaging across all channels.
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Practical strategies for entering new markets, establishing distribution channels, and scaling your product presence in retail and online environments.
How to approach and succeed with natural retailers, specialty stores, and big-box chains.
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Amazon, Shopify, and marketplace optimization for health and wellness products.
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Building relationships and sales programs for physician, nutritionist, and clinic distribution.
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Connect with trusted partners for packaging design, brand identity, and creative services. Build a professional brand that resonates with your target market.
Vetted packaging designers, graphic artists, and brand consultants experienced in health and wellness sectors.
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What your designer needs to know about regulatory requirements, materials, and print specifications.
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Protect your innovations and understand IP strategies for formulations, delivery systems, and proprietary processes.
Understanding composition patents, method patents, and freedom-to-operate considerations.
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Best practices for maintaining confidentiality of proprietary formulations and processes.
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Connect with intellectual property attorneys specializing in pharmaceutical and nutraceutical innovations.
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Technical resources on formulation development, ingredient compatibility, stability optimization, and scale-up processes.
Step-by-step approach to developing stable, efficacious formulations from concept to commercialization.
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Common ingredient interactions, stability concerns, and formulation considerations.
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Transitioning from laboratory to pilot to commercial manufacturing without compromising quality.
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Techniques for improving absorption and efficacy of active ingredients.
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Comprehensive training materials for your team on cGMP practices, quality systems, documentation, and regulatory compliance.
Essential training on current Good Manufacturing Practices for pharmaceutical and dietary supplement operations.
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How to create and maintain SOPs, batch records, and quality documentation that meets audit requirements.
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Practical training on HPLC, GC, spectroscopy, and other analytical techniques used in quality control.
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Prepare your team for internal auditing and external audit readiness.
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Can't find what you're looking for? Our technical team can create custom guides, training materials, or documentation specific to your project needs.
