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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

 

 

 

 

 
Global regulatory expertise

Gap Analysis 

TRIPHASE provides drug product development consulting services in the area of regulatory compliance gap analysis of product development plans and submissions.

Regulatory Preparation and Representation

We help prepare for and/or participate in regulatory authority meetings including developing meeting information packages and responses to regulatory requests from pre-IND to pre-approval inspections (PAI) and post-approval requirements.

Regulatory Filings

TRIPHASE regulatory experts can plan, manage, review, write and submit in eCTD compliant format technical sections and summaries for regulatory filings, including IND, IMPD, orphan drug designation applications, amendments, CTA, NDA, ANDA, DMFs,  Investigator’s Brochure (IB), annual reports, amendments, etc. We have supported development and commercial submissions in the US, Canada, Asia and Europe.Creative concise scientific writing:  Our CEO is a published literary author as well as author of over 30 scientific publications and patents.  He knows how to present your science concisely and in the best light to support your goals gained from writing over 50 regulatory filings.

US Agent Services

We can act as the US Agent for US-based regulatory submissions from non-US sponsors
Regulatory compliance Q7A, 21 CFR Parts 210-211 and ICH compliance

 
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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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