SERVICES

Methodology & Laboratory Consulting

Design methods & labs that deliver reliable results.

At FC&T, we focus on helping you & your laboratory partners design, validate, & improve the methods & environments that generate your data. We work across analytical & microbiological methodologies, supporting dietary supplements, OTC drugs, & related products, so your teams & partners can produce consistent, decision-ready results.

With a deep understanding of ANSI, ISO, AOAC, USP, FCC, BAM, and more accredited methods and references, our scientists are equipped to handle any formulation or testing challenge that may arise.

Strengthening your methods & your lab

Our goal is simple: improve the reliability, clarity, & compliance of the data you depend on.

We help organizations that:

Are struggling with inconsistent or conflicting test results.

Need new or improved methods for novel ingredients, delivery systems, or products.

Are building or expanding laboratory capabilities & want to avoid costly missteps.

Need a technical partner who understands both regulations & day-to-day lab realities.

Our work focuses on:

Developing, assessing, troubleshooting, & optimizing analytical & microbiological methodologies.

&

Supporting lab layout, efficiencies, workflow, & SOP improvements.

Method Development & Validation

Robust methods are the foundation of trustworthy data. We help you design, refine, & validate methods that fit your products, matrices, & regulatory context.

We can support you with:

Selecting appropriate analytical & microbiological techniques.

Developing new methods for novel compounds, delivery systems, or challenging matrices.

Optimizing existing methods that are noisy, slow, or unreliable.

Designing & documenting validation protocols (accuracy, precision, robustness, etc.).

Reviewing methods from internal or external labs to identify gaps, risks, or improvement opportunities.

Whether you’re working with HPLC, ICP-MS, spectroscopy, plate counts, PCR, or other techniques, we focus on making sure the method is fit for purpose & defensible.

Laboratory Development & Improvement

A good method can still fail in a poorly designed lab. We work with your team to create lab environments that support precision, safety, & efficiency.

We can support you with:

Lab layout & space planning for new or expanding facilities.

Workflow mapping to reduce bottlenecks & turnaround times.

Sample handling & chain-of-custody practices to protect sample integrity.

Instrument strategy: selection, utilization, data integrity, & basic lifecycle planning.

SOPs & training support for key processes, tests, & quality-critical tasks

We help you align the physical & procedural design of your lab with the quality of data you expect.

Need to strengthen your methods or lab operations?
Contact FC&T to discuss your methodology & laboratory consulting needs & see how we can help improve the quality & reliability of your testing programs.

Example Areas of Methodology & Testing Strategy

We support method development, validation, & testing strategies in the following areas:

We support the development, optimization, & validation of methods used to test finished dietary supplement products. This includes strategies for potency, identity, impurities, microbiological quality, & other critical attributes, and how these tests are integrated into your overall quality program.

We help design & refine methods for raw material & dietary ingredient testing, including supplier qualification, incoming inspection plans, & specification strategies to manage risk across your supply chain.

We assist in selecting techniques, designing methods, & validating potency assays to ensure label claims are supported with reliable, reproducible data across lots, formats, & manufacturing sites.

We support the development & review of identity testing strategies – including method selection, validation, & acceptance criteria – to help you comply with regulatory expectations while maintaining practical workflows.

We help design microbiological testing programs & methods for raw materials, in-process samples, & finished products, aligning test types, limits, & frequencies with product risk, regulations, & facility controls.

We assist in creating heavy metal testing strategies & methods (e.g., ICP-MS) appropriate to your product types, markets, & regulatory obligations, including Prop 65 risk considerations & retailer requirements.

We support method selection & validation for allergen testing, as well as program design for when & where to test, so your controls align with labeling, risk, & manufacturing realities.

We help design stability study protocols, select appropriate analytical & microbiological endpoints, & interpret results so you can set shelf-life & storage conditions with confidence.

We assist in building testing strategies & methods that address platform-specific expectations (such as Amazon) for adulterants & quality, helping you avoid listing disruptions driven by incomplete or misaligned testing programs.

We support the development & optimization of dissolution & disintegration methods for tablets, capsules, & other oral dosage forms. This includes selecting appropriate apparatus & conditions, defining acceptance criteria, & validating methods so release characteristics are meaningful, reproducible, & aligned with product claims and regulatory expectations.

We support the design & optimization of probiotic enumeration methods & strategies (e.g., plate counts, flow cytometry) so label claims for CFU counts are backed by robust data throughout shelf-life.

We help develop water testing strategies & methods appropriate to your processes (e.g., purified, RO, or USP water for manufacturing), aligning limits & frequencies with regulatory & quality expectations.

We assist in designing environmental monitoring programs & methods that fit your facility, products, & risk profile, including sample plans, action limits, & integration with broader quality systems.

We help design pesticide residue testing strategies & methods for botanical ingredients & finished products. This includes selecting appropriate analyte panels, methods, & limits based on source materials, markets, & regulatory expectations, then integrating those tests into your overall quality program.

Don’t see your specific test type? Contact Us – we often support method development, validation, & testing strategies beyond the examples listed here.