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FinnBrit Consulting advises on drug formulation, excipients and provides experiences expert witness

A successful formulation of a drug is an essential part of the drug development process. We provide assistance from preformulation through process design, development to manufacturing of the finished medicinal product.

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FinnBrit Consulting advises on drug formulation, excipients and provides experiences expert witness | finnbrit.com Reviews
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A successful formulation of a drug is an essential part of the drug development process. We provide assistance from preformulation through process design, development to manufacturing of the finished medicinal product.
<META>
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1 Drug formulation
2 excipients
3 expert witness
4 preformulation
5 process design
6 drug manufacturing
7 regulatory framework
8 formulation design
9 analytical method development and validation
10 fundamentals of bioavailability and bioequivalence clinical studies
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PAGE
publications,presentations,patent preparation,expert witness,new product acquisition,drug delivery systems,preformulation,feasibility and stability,quality by design,ind cmc documentation,bioavailability,process optimization,analytical methods,regulatory
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FinnBrit Consulting advises on drug formulation, excipients and provides experiences expert witness | finnbrit.com Reviews

https://finnbrit.com

A successful formulation of a drug is an essential part of the drug development process. We provide assistance from preformulation through process design, development to manufacturing of the finished medicinal product.

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1

Due Diligence for intellectual property or drug delivery assessment or drug in-licensing

http://www.finnbrit.com/duediligence.html

Formulation and Process Design. Analytical Method Development and Validation. Reverse Engineering of Pharmaceucial Formulation. Scale-Up and Clinical Manufacture. Quality By Design for Excipients. Due diligence is a requirement in any contractual dealings. In the specific context of pharmaceutical formulation and technology there are a number of different types of technical due diligence that can apply, viz:. Eg does the patent art give sufficient exclusivity? Drug delivery technology assessment. For dru...

2

Publications by Chris Moreton

http://www.finnbrit.com/SubPages/Background/publications.html

Formulation and Process Design. Analytical Method Development and Validation. Reverse Engineering of Pharmaceucial Formulation. Scale-Up and Clinical Manufacture. Quality By Design for Excipients. The publications are arranged by topic, rather than by date in order provide a better overview of the collection. Publications about Dosage Forms. Monographs for the Handbook of Excipients. Chris has additionally provided reviews and critiques of papers for Drug Development and Industrial Pharmacy. 4), 475 - 487.

3

Patent Preparation for the Pharmaceutical Industry

http://www.finnbrit.com/SubPages/IntellectualProperty/patentdrafting.html

Formulation and Process Design. Analytical Method Development and Validation. Reverse Engineering of Pharmaceucial Formulation. Scale-Up and Clinical Manufacture. Quality By Design for Excipients. FinnBrit Consulting can provide the appropriate scientific knowledge and experience to aid the patent drafting process for formulation patents to minimize problems that may arise in the future.

4

Quality by Design QBD for drug development and excipients

http://www.finnbrit.com/SubPages/Formulation/qbd.html

Formulation and Process Design. Analytical Method Development and Validation. Reverse Engineering of Pharmaceucial Formulation. Scale-Up and Clinical Manufacture. Quality By Design for Excipients. Quality by Design' (QbD) is one of a series of programs from the FDA that is part of their 'Quality in the 21st Century' initiative. In summary, this program emphasizes the fact that quality cannot be tested into anything, it has to be built in. You can watch an interview on YouTube.

5

Preformulation of Pharmaceutical Drugs

http://www.finnbrit.com/SubPages/Formulation/preformulation.html

Formulation and Process Design. Analytical Method Development and Validation. Reverse Engineering of Pharmaceucial Formulation. Scale-Up and Clinical Manufacture. Quality By Design for Excipients. Preformulation provides the necessary understanding of the physicochemical properties of the API underpinning the total formulation development. It is the foundation upon which success can be built. FinnBrit Consulting has experience gained over many years and across many different types of API, and can provide...

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Who We Are - The Additive Advantage

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The Additive Advantage is a privately owned application engineering company founded in 2006. The company also operates as a licensing entity. The corporation currently maintains a research laboratory, engineering facility and sales office in North Reading, Massachusetts, as well as a West Coast sales office in Scottsdale, Arizona. Salvatore Celeste, CEO/Chief Scientific Officer. John Fitzpatrick, President. Jerry Brown, Sales Director. Zak Kraft, Operations Director. Lou DeSantis, Marketing Director.

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FinnBrit Consulting advises on drug formulation, excipients and provides experiences expert witness

Formulation and Process Design. Analytical Method Development and Validation. Reverse Engineering of Pharmaceucial Formulation. Scale-Up and Clinical Manufacture. Quality By Design for Excipients. Pharmaceutical products have complex and extended development cycles with an absolute minimum of at least five years for a new innovator product, and more than 3 years for a generic drug. Every extra day prior to launch costs money! An inadequate patent may result in a future loss of an infringement suit agains...

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