BioChroma Analytical sets itself above all other service facilities by providing multiple service offerings. In addition to the one shop stop, 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. We are here to educate and help you fully understand what you should test and why!
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 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 Analytical Laboratories provides high-level analytical and R&D service in the following categories:
- Shelf Life Studies
- Microbial Quality Analysis (quantitative)
- Pathogenic Bacteria Analysis
- Preservative Efficacy
- Water Suitability
- Microbial ID
- Microscopic Examination
- Environmental Monitoring (sampling supplies provided by BioChroma Analytical Labs)
- Raw Material Identification
- Wet Chemical Techniques (Moisture, pH, titrations, etc.)
- Active Ingredient Assay
- Nutritional Analysis
- Method Development and Validation to Compendia Standards
- Real Time
- Forced Degradation
This service provides our customer’s assistance with 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.
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