FDA & Supplement Compliance Consulting

Compliance Simplified.
Quality assured.

Over 20 years of experience translating complex regulations into accessible, practical guidance for food, supplement, OTC, and cosmetic brands.

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20+Years of experience

1,000sProducts reviewed

19Specialized services

What we do

How we help

Three ways we keep your products safe, compliant, and market-ready.

Consulting & advising

Get the right advice to maintain the highest quality and stay in compliance with regulations specific to your products and markets

Problem solving

Real solutions for when you need the job done right. We can create and implement your quality and compliance systems

Training & guidance

Training for your staff so you can continue to sustainably stay in compliance with regulations and have the resources you need

Who we serve

Built for every stage of growth

From first product to full enterprise scale — and everyone in between.

BUILT FOR GROWTH

Brands

We partner with emerging and established brands to navigate compliance, quality systems, and scale with confidence and integrity.

SAFE SUSTAINABLE CREATION

Manufacturers

From GMP documentation to supplier verifications, we help manufacturers stay compliant, competitive, and aligned with evolving regulations.

GLOBAL READINESS

Import/Export

Sci Strive supports international trade by managing product registrations, labeling, and documentation required for import and export.

PROTECT YOUR INVESTMENT

Investors/VC

Our expertise helps investors identify regulatory red flags, reduce liability, and strengthen the operational foundation of their portfolio companies.

About us

The intersection of science, law, and human connection.

What truly drives me is the fascinating intersection of science, law, and human connection.

More About Us

★

Amber Rowley

Founder & principal consultant with over 20 years of experience in regulatory compliance, quality systems, and product safety.

Our specialties

What we do best

These are the most common needs of our clients that we specialize in.

ACCURATE & LEGAL

Label Reviews

Our label review process checks for accuracy, legal compliance, and marketing claims so your products are shelf-ready and audit-proof.

REGISTERED & READY

FDA Registration

We guide you through the FDA registration process to ensure your facility and products are properly listed and compliant from day one.

TOTAL QUALITY SYSTEM

Full QMS

We design and implement a full QMS tailored to your operations, ensuring compliance, consistency, and continuous improvement.

CONSISTENT QUALITY

QC Program

Our quality control solutions help you monitor, measure, and maintain product integrity while meeting regulatory and brand standards.

Our services

Our complete approach to compliance

Custom compliance and quality services for dietary supplements, food & beverage, OTC, and cosmetics. Every engagement is scoped and quoted individually.

Quality Management & Systems

Full QMS ImplementationCreation and implementation of your custom Quality Management System from top to bottom, with ongoing maintenance.Learn more →Facility-Wide Software Systems Integration with QMSIntegrating your QMS with facility-wide software like MES, ERP, and automation tools for inventory, orders, and equipment.Learn more →Standard Operating Procedures (SOPs)Audit-proof your systems with efficient SOPs built on industry best practices for your certifications.Learn more →Customer Service ComplianceCompliant handling of reviews, testimonials, and customer complaints to avoid litigation and regulatory action.Learn more →Fractional Quality Manager ServicesFull quality management services at a fraction of the cost of hiring a full-time employee.Learn more →

Labeling, Claims & Product Communication

Formula Compliance ReviewsFormula reviews for safety, efficacy, restricted ingredients, retailer requirements, GRAS, and monographs.Learn more →Label Compliance ReviewsLabel reviews and risk assessment for regulatory and litigation triggers across supplements, food, OTC, and cosmetics.Learn more →Marketing Claims SubstantiationClaims dossiers with clinical proof that protect you from regulatory triggers and satisfy large retailers.Learn more →SFP/NFP Creation & ReviewCreation and review of Supplement Facts Panels and Nutrition Facts Panels to stay compliant.Learn more →Safety Data Sheet CreationSafety data sheets for OSHA requirements and retailer-specific demands such as Amazon.Learn more →

Facility Registration & Supply Chain

FDA ListingsFDA facility registration, cosmetic product listing, and National Drug Code (NDC) acquisition.Learn more →Food Safety Plan CreationFood safety plans with HACCP and HARPC hazard and risk assessments.Learn more →Supplier QualificationsSupplier approval programs including supplier audits and foreign supplier verification.Learn more →

Testing & Specifications

Quality Control TestingComplete quality control testing, lab qualification, method selection, limit setting, and more.Learn more →SpecificationsSpecification sheets including spec selection, methods, limits, and lab-capability reconciliation.Learn more →

Certifications

GFSI Certification AssistanceCertification preparation, gap assessment, audit assistance, and GMP certifications.Learn more →Other CertificationsSupport for USDA Organic, Kosher, Halal, Leaping Bunny, Clean Label Project, and more.Learn more →

Lifecycle & Compliance Response

Startup Compliance ChecklistThe right information to get you up and running from a compliance perspective, protected from bad actors.Learn more →FDA 483 & Warning Letter ResponsesDocumentation and remediation that prevents escalation without providing ammunition.Learn more →

Testimonials

Trusted by brands on the shelf

"Working with SciStrive was an absolute game-changer for our supplement launch. Amber and her team helped us navigate the entire FDA registration process with clarity and confidence. They caught things in our formula and label that we never would have noticed — and saved us from potential delays or costly rework. Their attention to detail and responsiveness made us feel like we had an in-house regulatory team. I can’t recommend them enough."

JANE DOE

"We’d been struggling to get our product compliant after a few failed attempts with other consultants. SciStrive not only fixed what was wrong, but also helped us build the foundation for long-term quality control. Their guidance on SOPs, claims substantiation, and FDA submission prep was top-notch. It’s rare to find a partner who truly cares about your success — SciStrive is that partner."