Services

Analytical Laboratory Services

Testing, consulting, and development support for product quality and compliance

BioChroma Analytical sets itself above all other service facilities by providing multiple service offerings. In addition to the one-stop shop, BioChroma Analytical sets the bar for customer service. Our business attitude is service first. Use us as your own scientific group to guide you through difficult decisions about testing and how it relates to quality of your product.

There is a growing need to instruct and guide prospects on proper methods of testing and interpretation of results. Different regulatory agencies recommend, and sometimes require, different analytical methods. BioChroma Analytical Labs, LLC has scientists with years of experience on selection of test methodology and they are here to guide clients through understanding how the results impact their product and business.

BioChroma provides third-party analytical testing and related support for product quality, regulatory, and marketplace compliance. Some clients use this work to support products sold through online marketplaces such as Amazon.

Pricing is quote-based and varies depending on product type, testing requirements, and project scope.

BioChroma Analytical Laboratory, LLC is accredited by PJLA to ISO/IEC 17025:2017 for Biological and Chemical Testing. Accreditation No. 105837. Scope applies only to accredited activities.

Common Testing Services Include

  • Heavy metals analysis
  • Active ingredient verification and concentration testing
  • Microbiological testing
  • Stability and shelf-life studies
  • Method development and validation

Representative Support Areas

  • Testing dietary supplements for regulatory and marketplace compliance
  • Active ingredient verification for cosmetics and topical products
  • Heavy metals screening for beverages and consumer products
  • Microbiological testing for OTC and personal care products

Microbiological

These tests follow compendia methods such as USP, AOAC, FDA BAM and USDA.

  • Shelf Life Studies
  • Microbial Quality Analysis (quantitative)
  • Pathogenic Bacteria Analysis
  • Preservative Efficacy
  • Endotoxin
  • Water Suitability
  • Microbial ID
  • Microscopic Examination
  • Environmental Monitoring (sampling supplies provided by BioChroma)

Chemical

These tests follow compendia methods such as USP, AOAC, FDA BAM and USDA.

  • Raw Material Identification
  • Wet Chemical Techniques (Moisture, pH, titrations, etc.)
  • Active Ingredient Assay
  • Nutritional Analysis
  • Allergen
  • Toxin
  • Pesticide
  • Method Development and Validation to Compendia Standards

Stability

  • Real Time
  • Accelerated
  • Stress
  • Forced Degradation

Consulting

This service provides our customers with assistance in all aspects of manufacturing.

  • Ingredient Stability & Product Formulation Advice

    Not all ingredients are stable and there are many conditions that affect stability including pH, temperatures required for proper processing and exposure to light. To create a product with appeal, good efficacy (if so desired) and remaining in the same condition from the time it was manufactured until the expiration date requires knowledge and experience with the ingredients.

  • Packaging & Container Closure Advice

    The content of a formula dictates the types of packaging and closures to be used. This is not a decision to be taken lightly because it can affect the shelf life and aesthetics of the product.

  • Contract Manufacturer Plant Selection/Inspections

    For anyone new to the world of manufacturing, selecting a contract manufacturer will likely be a major task. We can help provide assurance that you are selecting the perfect fit for your product.

  • Quality and Regulatory Advice

    The Code of Federal Regulations (CFR) is the document provided by the Executive Branch of the US Federal government which provides rules that govern our industry. The Food and Drug Administration (FDA) has the legal authority to regulate this law. Once a product is ready to hit the store shelves is not the time to start becoming familiar with this entire process. It can be very overwhelming and discouraging but there is no reason to let it derail new and unique product ideas. Take it in stride and start implementation of quality during the early stages of development. We are here to help with establishing a quality program and provide advice on label do's and don'ts.

Laboratory Studies

These studies are not part of regulatory GMPs. Methods in this category are to demonstrate the function of a product.

  • In vitro Bioavailability
  • Skin Permeability
  • Enzyme Assays
  • Inhibition Assays
  • Antibiotic Efficacy
  • Microbial Kill Studies
  • New Method Development to Fit Customer Needs