supply quantities from research needs (500g), up to full scale manufacturing
and metric ton quantities.
do I order?
A. To inquire, or place an order you can: Call (512) 255-6877
Fax (512) 255-8298
your products "FDA-Approved"?
manufactures chemicals that are covered under a number of different FDA regulations,
depending on the applications.
I use your chemicals in my clinical research trials?
but it will depend on the use of the chemical, and your stage of trials.
FMLP works collaboratively with customers that come to us in all stages of clinical trials, in which our chemicals are used varying ways (e.g., active pharmaceutical ingredients, processing aids, etc). We will work with you to ensure that regulatory requirements for our chemicals in your application are met.
Q. I already use a fluorochemical from another vendor in my FDA-regulated products. How do I change suppliers to use your product within the framework of FDA regulations?
that will depend on the chemical and its use, and the stage of your product
development. Our regulatory staff has the knowledge to ensure a smooth change
of suppliers throughout the regulatory spectrum, and will assist your staff
to maintain compliance while making the change.
is the difference between PFCs that are "suitable for use in finished
pharmaceuticals and as a medical device component" and PFCs that are
supplied as "research grade only, not suitable for use in humans except
under an approved protocol"?
difference in the status of the chemicals refers to the stage of regulatory
compliance of the manufacturing process.
To be considered "suitable for use in finished pharmaceuticals", the product is fully GMP-compliant, meaning all processes (manufacturing, cleaning, testing) are prospectively validated; stability studies are underway; and the appropriate regulatory submissions have been filed by FMLP or by the sponsor.
Prior to this point, products are still manufactured under GMP, and can be used in human studies under an approved protocol, such as an IND (investigational new drug application). Full prospective process validation is not yet complete, and submissions may not yet be filed.
we perform quality and GMP audits of your facility and processes?
welcomes our customers to perform full audits in accordance with GMP requirements,
and hosts numerous such inspections each year.
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