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"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

"Success is the ability to move from failure to failure with no loss of enthusiasm."

Winston Churchill






 Please check back as new papers are added on a regular basis.

"Small Molecule IND Development Plan"


Learn what a typical IND plan looks like and obtain cost estimates for each task.  Read more in our white paper...

"Addressing Genotoxic Impurities in Drug Development"


Recently the FDA has been requiring compliance to a recent guidance on the control of potential mutagenic substances in your synthesis or degradation by-products.  Last year TRIPHASE had 2 clients come to us on clinical hold due to this problem.  Read more about this #1 "risk area" in our white paper...

"Top 5 CMC Reasons to Put Your program on Clinical Hold"


Stability issues and a poor understanding of impurity profiles in your toxicology and clinical batches is a risky proposition.  Learn about the top risk areas that put most Biotechs on clinical hold...

"Drug Development Strategies- QbD Approaches for  Pre-formulation and Formulation"


Learn the most current thinking and learn about a typical small drug development program key quality considerations for preformulation and formulation...

"Regulatory Starting Materials- A Case Study for the Virtual Drug Company"


Learn the most current thinking at the FDA about the selection and justification of regulatory starting materials for API. A review of the regulatory guidance history as Q11 is provided followed by a case study which includes actual FDA comments back on the selection of RSMs from a recent pre-IND submission...


"Partners for Outsourcing Carry Special Risks"

Food & Drug Letter, 24 April 2009 Vol. , No. 819


Learn the FDA's most current thinking about small Biotech's and outsourcing.  Learn their expectations before you run into trouble.  Read more in our white paper...

Did you know that FDA Letters are often a precursor to a Guidance which is a precursor to law???  


"Pre-IND and Scientific Advice Meetings"


Let TRIPHASE take your complex chemistry and summarize in a concise well-written summary for a Pre-IND or Scientific Advice meeting package. Read more in our white paper paper...


"ICH Q3D Case Study"


ICH Q3D “Elemental Impurities” became the official guidance in September 2015 governing heavy metals and catalyst impurities in drugs for the European Union, Japan, and the United States. Prior to ICH Q3D the “official” Guidance was USP <231>. Now that ICH Q3D is official it should be the first choice for the setting of specifications for metal limits in drug substance and drug product.  As our case study illustrates, ICH Q3D allows for higher levels of metals based on projected daily dose in grams of drug product than possible under ICH <231> which is fixed at 10 ppm per metal or 20 ppm total.  Read more in our white paper paper...


"Toxicology Studies- GMP or non-GMP?"


This white paper addresses the cost - benefit considerations in using either non-GMP or GMP drug substance and/or formulated drug product (test article) in your GLP studies. Three different batch matrix options are presented comparing the cost, time, and risk. Key words are test article GLPs, non-GMP vs. GMP manufacture, GLP testing, impurity tracking, CDMO report deliverables required to populate IND Module 3 pertinent to drug substance and drug product used in your GLP and proposed clinical studies...


"FDA is Driving the Manufacture of Drug Products Outside the United States"


This is an important review by www.FDALAWBLOG.Net of the law governing the manufacture of clinical drug substance overseas planned for import for USA based manufacture of the clinical drug product at the pre-IND stage. In short, drug substances (APIs) can not be manufactured overseas then imported and formulated into clinical supplies in the USA without an open IND.  One usually does not file an IND without the drug product manufacturing and release information in Module 3 but if you can't ship API to be formulated w/o an open IND how does one deal with this dilemma?  Your overseas API CRO may not be as transparent here as you would like. Feel free to contact us to discuss this issue in detail and hear options available to circumvent and / or comply with this law...


"Corona Virus Hygiene: Preparation and Use of Disinfectant Solutions"


With the anticipated limited supply of disinfectant solutions for the general public this white paper provides instructions for the preparation of disinfectants that can be purchased and/or  made at home and used to help reduce transmission of the Corona Virus. Additional tips are provided on how to manage activities such as shopping, receipt of packages, and other potential transmission risks. Links are provided to key sources such as the US and China Center for Disease Control and EPA approved commercial anti-viral disinfectants.





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