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TRIPHASE BROCHURE

"If an experiment does not hold out the possibility of causing one to revise one's views, it is hard to see why it should be done at all."

-Peter Medawar
1960 Nobel Laureate

"If you don't have time to do it right, when will you have time to do it over?"

-John Wooden
Basketball Coach

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

-John Wooden
Basketball Coach

"Intellectuals solve problems, geniuses prevent them."

-Albert Einstein

"Strive not to be a success, but rather to be of value."

-Albert Einstein

"The whole of science is nothing more than a refinement of everyday thinking."

-Albert Einstein

"Whoever is careless with the truth in small matters can not be trusted with important matters."

-Albert Einstein

"I start where the last man left off."

-Thomas A. Edison

"Hard work doesn't guarantee success, but improves its chances."

-Thomas A. Edison

"Success is dependent on effort"

-Sophocles (496-406)

"Show me a thoroughly satisfied man and I will show you a failure."

-Thomas A. Edison

"The three great essentials to achieve anything are hard work, stick-to-itiveness, and common sense."

-Thomas A. Edison

"What you are will show in what you do."

-Thomas A. Edison

"Opportunity is missed by most people because it is dressed in overalls and looks like work."

-Thomas A. Edison

"When one door closes, another opens; but we often look so long and so regretfully upon the closed door that we do not see the one that has opened for us."

-Alexander Graham Bell

"He who asks a question is a fool for five minutes; he who does not ask a question remains a fool forever."

-Chinese Proverb

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

-Louis Pasteur

"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"

- Anonymous

"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."

- Anonymous

 

 

 

 

 

TRIPHASE provides drug product development consulting services in the area of initial synthesis of your lead NCE to execute key GLP studies. We will manage all aspects of your preclinical program required for submission of a successful IND or CTA/IMPD. We provide a full range of coordinated regulatory and technical services including:

  


Drug Substance       

  • Complex synthesis; scope assessment, RFP preparation, and vendor selection

  • Process development; new route design, process changes, specifications

  • Impurities, crystallization, polymorph, salt forms, particle size, milling

  • On-site and remote manufacturing oversight and batch releases

  • Off-shore API, starting materials, intermediate sourcing

  • IP literature and patent searches: CAS, CrossFire Data bases 

  • Cost of Goods calculations and “redesign” of synthetic routes to cut costs

  • Identifying raw materials sources and manufacturing sites 

  • Manufacturing supplies for GLP and clinical studies 

  • Phase appropriate specifications

  • Characterization; data analysis- HPLC, GC, Mass Spec, NMR, DSC, TGA, XRD 

Drug Product

  • Pre-formulation: polymorph, salt form screening and selection, scale-up 

  • In-vitro and in-vivo equivalence testing

  • Setting of specifications

  • Stability study design, problem solving

  • Analytical chemistry; assays and specifications, stability studies

  • Formulation of dosage forms (oral, injectable, topical, ophthalmic, inhalation, drug-device combinations)

  • Pre-formulation studies to support effective formulation development

  • Clinical trial materials CRO identification and management

Development Plans

  • Define comprehensive drug substance and formulation (CMC) requirements based on toxicology and clinical requirements and prepare Request for Proposals (establish program "scope of work").

  • Identify best CROs for your scientific needs and manage CROs as required to ensure success.

  • Incorporate data and information into a final document in CTD paper and/or electronic format.

  • Provide development plans suitable for inclusion in investor meetings or proposals

  • Write development reports for inclusion in regulatory submission

Analytical / Impurities

  • Drug substance and drug product analytical method development and validation

  • Data analysis and setting raw material, API, and product specifications 

  • Genotoxin structure alert assessments; determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

  • ICH Q3A impurity assessment and solving impurity issues

 
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 "TRIPHASE®" is a registered trade mark USPO serial number 77-964,084.  © 2010 TRIPHASE® Pharma Solutions, LLC. All Rights Reserved.

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