A Drug Master File
(DMF) is a confidential detailed document submitted to the FDA by a manufacturer that includes the Chemistry, Manufacturing and Controls (CMC) information about their product.
Full descriptive data for each of these basic styles is stored on the product master file
-- style code, wood finish, cushion type and all customer options.
PharmaVigilant's I-Vault (eTMF) Solution will be used to start new Electronic Trial Master Files
Product and Master File
information is listed below and customers may request a cross reference to the Master Files
for the products using the following link: BioLife Solutions Master File
Cross Reference Request Form.
The MG grade is certified to the same manufacturing process as OXPEKK IG and is tested for cytotoxicity, but is restricted to non-implant applications and has no Master File
access and no biocompatibility certification.
An annual shutdown of master file
operations for system maintenance causes inappropriate levies and subsequent refunds.
On May 5 at 3 pm EDT, RollStream's founder and COO, Nick Parnaby, will present "Your Supplier Master File
Department Commerce to effectuate the new law, Title II of Section 203 of the Bipartisan Budget Act of 2013, governing access to the Death Master File
I-Vault is the only commercially available Electronic Trial Master File
system in the industry providing the industry with the first electronic end to end solution.
9, 2013 /PRNewswire/ -- NextDocs, a leading provider of regulated content management and compliance solutions used in clinical trials today released its first report examining the state of Trial Master File
(TMF) management in the life sciences and pharmaceutical industry.
Case Studies Examine Practical Approaches for Transitioning from Paper Trial Master File
June 11, 2013 /PRNewswire/ -- NextDocs announced today that it will be co-presenting with Sanofi, the global and diversified pharmaceutical company, in a webinar examining how life sciences companies can streamline paper-based Trial Master File
(TMF) processes using electronic TMF (eTMF) systems and clinical trial portals.