PHARMACY

May 14 2020

CMC Drug Product Development Regulatory Consulting Pharma, cmc pharma.

#Cmc #pharma



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We are here to help. Just e-mail or call us with your CMC questions

1960 Nobel Laureate

It’s the little details that are vital. Little things make big things happen.

Let me tell you the secret that had led to my goals; my strength lies solely in my tenacity.

Nobody is right all the time and even a broken clock is right two times a day.

-Bill Clinton on need to work together to solve problems DNC 2012

Good science doesn’t happen when people are keeping their heads down. You need a raucous, rowdy discussion

The great tragedy of Science is the slaying of a beautiful hypothesis by an ugly fact.

Thomas H. Huxley, Biogenesis and Abiogenisis

Many consultants can ‘turn the crank’ but only few know ‘when to crank, which crank to turn, which direction to crank, or how many turns.

Cmc pharma

Cmc pharma

Cmc pharma

TRIPHASE ® Pharma Solutions, LLC, provides drug development consulting in chemistry, manufacturing, and controls (CMC) for drug substance, analytical, pre-formulation, formulation, salt polymorph selection, cGMP/GXP manufacture of toxicology and clinical supplies, stability, impurities, specifications, pre-IND and EU Scientific Advisory Meeting regulatory filings to support an IND, IMPD, NDA, 505b2, or ANDA in CTD format. Therapeutic areas of expertise include dermatology, ophthalmology, cardiology, and oncology. Triphase is seeking partners in these areas to develop drugs under a consultancy (partnering) model. From the inception of your project to submission we provide the essential scientific and regulatory leadership to manage your program in all areas such as toxicology drug supplies, clinical drug supplies, analytical validations, formulation of oral solid or liquid dosage forms, sterile liquids for ophthalmic or injectable use, lyophilized products, manufacturing compliant to GMP, ICH, ISO, QA/QC audit and oversight, stability study design and problem solving (impurities), specifications, and consolidation all your data into a coherent regulatory filing to obtain your approvable letter. Please learn more by reading about our services or contact us directly at info@triphasepharmasolutions.com.

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