Certifications & Quality
Quality is not a feature at APEX Contract Supplement Manufacturing—it is the operating system. Our role is to help brands manufacture supplements within FDA- and cGMP-certified environments, supported by disciplined processes, defensible documentation, and testing strategies aligned to real-world distribution requirements.
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Built Around Compliance
APEX CSM partners with FDA- and cGMP-certified facilities operating under established SOPs designed to protect label accuracy, consumer safety, and brand credibility across every production run.
FDA Oversight Alignment
Manufacturing environments adhere to FDA dietary supplement regulations, with documented controls for ingredient handling, production, sanitation, and recordkeeping.
cGMP-Certified Operations
Current Good Manufacturing Practices guide every stage of production—from raw material intake to finished product release—supporting repeatable outcomes and defensible quality standards.
Documented SOPs
Standard Operating Procedures govern production workflows, deviation handling, and corrective actions, ensuring consistency across batches and reorders.
Quality Control & Testing
Quality control is designed around risk management and transparency. Testing protocols are selected based on formulation, ingredient profile, delivery format, and channel expectations—never one-size-fits-all.
Raw Materials
- Identity verification
- Potency confirmation
- Supplier COA review
- Risk-based testing alignment
In-Process Controls
- Weight and fill checks
- Blend uniformity oversight
- Environmental monitoring
- Deviation documentation
Finished Goods
- Identity and potency testing
- Microbial screening
- Heavy metal analysis
- Specification verification
Release Review
- COA reconciliation
- Batch record approval
- Lot code assignment
- Release authorization

Documentation That Scales With You
Quality documentation is often the difference between a smooth audit and a delayed launch. We treat paperwork as part of the product—not an afterthought.
Traceability & Lot Control
Each production run is supported by lot-level traceability, enabling consistent reorders, recall readiness, and confidence across distribution partners and marketplaces.
Audit-Ready Records
Batch records, test results, and release documentation are maintained to support retailer reviews, marketplace compliance checks, and internal quality audits as your brand grows.
COAs You Can Defend
Certificates of Analysis are aligned to your specifications and testing plan, providing clarity and confidence when stakeholders request verification.
Change Control Discipline
Formula, supplier, or packaging changes are managed through documented review processes to reduce variability and protect finished-goods consistency across production cycles.
Quality as a Competitive Advantage
Strong quality systems reduce friction everywhere—from retail onboarding to customer trust and repeat sales. APEX CSM is built to support brands that plan to scale responsibly.
Whether you are launching your first SKU or managing a mature product line, our quality-first approach helps protect your margins, your reputation, and your long-term growth strategy.
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