Regis Technologies, Inc. partners with pharmaceutical and biotechnology companies to expedite drugs to market. We offer unrivaled expertise in process chemistry and analytical development to scale your active pharmaceutical ingredients (API) from initial process development to validation and commercial manufacturing. From our extensive organic chemistry expertise and collegiate collaborations, we can deliver the added value of our innovative, proprietary chromatography products, especially those with a chiral emphasis. We continue to offer fine organic chemicals as we have for the past 64 years.
Mr. Anisfeld needs to get the facts right. Wockhardt started their manufacturing in 1967 and the hospital chain started in 1989. So the example of verticle integration is incorrect.
A DMF has five Modules 1. Cover Letter and Admin information, Letter of Authorizations 2. Summarizes the appropriate module 3 sections (and 4 & 5 if applicable) 3. For Type II: Drug Substance, Drug Substance Intermediate and Materials used in their preparation 4. Not necessary for DMFs unless non clinical evaluations are included in the DMF - i.e. an impurity in a Type II DMF 5. Submitted for clinical information only, such as a Type V DMF
HCl and NaOH are typical acids and bases used for hydrolysis conditions for forced degradation. This does not preclude the use of other acids/bases, as appropriate.
Excellent presentations. I have learned a lot that I can use in teaching my pharmacy students at Kabarak University in Kenya about what method development is all about.
For calculating Detection limits as per ICH Q2 by Linear regression and MS Excel. Refer the video ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-Ii2Z3hqwRGM.html
@@Registech Dear Sir, do u have any vacancy ? Have more than 5 years of Regulatory Affairs experience national & international, Pharma D, trained in PV and GCP.
