TRIPHASE Pharma Solutions

"Let me tell you the secret that had led to my goals; my strength lies solely in my tenacity." "Good science doesn't happen when people are keeping their heads down. You need a raucous, rowdy discussion" "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." TRIPHA... SE Pharma Solutions, LLC, provides drug development services in chemical engineering, 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 .Read More