Our seasoned technical staff has an average 25 years experience working with USP, NF, FCC and FDA-compliant products. We can help our customers with the selection of the right product for your application. They can recommend appropriate use concentrations and suggest alternative solutions or formulations to some of your product development issues. We stand behind our products! Our team will work closely with you to resolve any quality issues you encounter. If you need assistance, we will be there to help. In addition, we offer confidential and custom technical support for many customers domestically and around the world and invite your specific inquiries regarding how we can help.
The requirements for regulatory, quality and technical documentation have increased enormously over the last decade. Our team is here to provide you the proper documents you need quickly. As part of our supplier and quality product review and approval process, we collect and maintain an extensive database of product literature and documentation. We provide the documentation you need in an expeditious fashion. All types of product literature or supplier qualification information can be obtained, from a specification data sheet to a full product dossier requiring a master drug file, Supplier Evaluation questionnaires, audit information and supplier certifications. Our team will provide you with all that is needed to complete your documentation needs in a timely manner.
Available documentation
| Document Name | Product | Customer | Supplier |
|---|---|---|---|
| Supply chain statement | X | X | X |
| Foreign materials control statement | X | X | |
| Microbiological statement | X | ||
| Re-testing histories and documentation | X | X | |
| “Free of” statement applies to: Food additives, Cosmetics, Topical Uses | X | ||
| Allergen Statement (obtain for every chemical and flag in product code) | X | ||
| Animal Testing Statement | X | X | |
| BSE/TSE Statement (Bovine/Transmissible Spongiform Encephalopathy) | X | ||
| CMR statement (Carcinogenity, Mutagenity, Reproductive Toxicity) | X | ||
| COA (Mfr’s Original COA} | X | ||
| Composition/Contents statement | X | ||
| Copy of Manufacturer’s Label | X | ||
| Country Of Origin statement or NAFTA as applies | X | ||
| Derivation Statement (Which plant, animal, mineral, synthetic it comes from) | X | ||
| Fatty Acid Distribution | X | ||
| Gluten Statement | X | ||
| GMO statement – Genetically Modified Organisms | X | ||
| GRAS Statement (Generally Recognized As Safe) | X | ||
| Health Certificates | X | ||
| Heavy Metals Statement | X | ||
| Kosher Certificate (if Applicable) &, or Halal Certificate (if Applicable) | X | X | |
| Lot Code Explanation | X | ||
| Melamine Statement | X | ||
| Nanomaterial Statement | X | ||
| Natural or Synthetic Statement | X | ||
| Nutritional Profile | X | ||
| Organic Statement | X | ||
| Particle size statement | X | ||
| Phthalates statement | X | ||
| Prerequisitional vendor questionnaires | X | X | |
| Production Process Flowchart | X | ||
| Recommended Storage Conditions | X | ||
| Residual Solvents Statement or Test Data (Complies with Class 1, 2, 3, USP <467>) | X | ||
| SDS – Safety Data Sheet (MSDS) | X | ||
| Shelf Life Statement | X | ||
| Spec Change notification | X | X | |
| Spec Sheet with Shelf Life, Storage & Handling info | X | ||
| Stability Data | X | ||
| Incoming Raw Materials (procedure) | X | ||
| Manufacturer’s qualification of their supplier’s (procedure) | X | ||
| Process for sampling (procedure) | X | ||
| Recall procedure (procedure) | X | ||
| Test methods, testing records | X | ||
| Expired and rejected material (procedure) | X | ||
| FDA Bioterrorism statement | X | ||
| CAPA documents made public | X | ||
| cGMP Certificate/Statement (current good manufacturing practices) | X | X | |
| Continuing Guarantee Statement | X | ||
| FDA Registration Number | X | ||
| ISO Certificates and other 3rd party audit docs (HACCP, AIB, Siliker, etc) | X | ||
| Manufacturer/supplier name change notification | X | ||
| NDC Number | |||
| Organization Chart | X | ||
| RSPO, Roundtable on Sustainable Palm Oil (as applicable)” | X | ||
| Self Audit reports | X | ||
| Slavery Human Trafficking certificate | X |
