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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 has drug product development consulting and process development experience enabling its clients to transition their products from discovery to the clinic and to commercialization faster and with less expense and risk. Whether your product is in pre-clinical development, clinical trials, or already on the market, we can help increase its value by identifying opportunities for improving yield, product quality, scalability, process robustness, cost savings, and processing speed. Our expertise covers all aspects of CMC (Chemistry, Manufacturing and Controls), including:

Process Development

  • API Process Development; new route design, process changes, specifications

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

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

  • Drug product process development

Analytical Development

  • Analytical method development, qualification and validation

  • ICH Q3A impurity assessment and solving impurity issues

  • Phase-appropriate specification setting strategies

  • Stability studies

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

Manufacturing

  • Drug substance and drug product clinical and commercial manufacturing

  • Product life-cycle management

  • Process validation and validation master plans

  • Technology transfer and scale-up

  • Cost and process modeling, including new technologies

  • CMO Management

  • Quality Systems and Regulatory

  • GMP Auditing of API and drug product manufacturers 

  • Project Management; science-driven oversight and coordination of CROs to ensure "on-time" "on-quality" and "on-budget" delivery

  • Q7A, 21 CFR Parts 210-211 and ICH regulatory compliance. 

  • Interpretation of FDA and international regulations and guidelines

  • Represent company at FDA or other regulatory agency meetings

  • Maintain Quality Assurance responsibilities for virtual companies (e.g., batch record review, release of clinical supplies)

  • CMC regulatory strategy; Phase 1 through commercial.  QA, QC reviews

  • Maintain a Quality Assurance role for virtual organizations

  • Drafting SOPs for emerging pharmaceutical and biotech organizations

  • Transfer of CMC knowledge and responsibilities to newly hired professional

  • Facility design

  • Review architect and building contractor plans for GMP facility

GMP Compliance Assessments and Audits

  • Due diligence audits of prospective CMC contractors (qualification audits

  • GMP compliance assessments (of your organization or of CMC contractors)

  • Mock FDA Pre Approval Inspections

  • SOP and Documentation assessment

Regulatory Submissions

  • 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 including INDs, IBs, DMFs, NDA, ANDAs.

  • Primary CMC preparation, gap analysis, review and assessment of drug product development

  • Preparation of regulatory filings; Type II DMFs and CMC sections for IND, IMPD, NDA, ANDA in CTD format

  • Draft, write, review and/or compile CMC sections of IND, NDA, CTA, ANDA, DMF, CTD, eCTD format (Octagon, ISI) and other marketing applications

  • Write CMC sections of pre-IND, EOP2 and pre-NDA technical packages for meetings with FDA or other regulatory agencies

  • Write the P2 Pharmaceutical Development section of NDA applications

 
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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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