Tag Archives: EWG

FDA Puiblish Guidance on Q4B, Evaluation and Recommendation of Pharmacopoeial Text for Use in ICH regions, Annex 12 Analytical Sieving General Chapter

Posted on September 23, 2010 by admin| Leave a comment

FDA Publish Guidance on Q4B, Evaluation and Recommendation of Pharmacopoeial Text for Use in ICH regions, Annex 12 Analytical Sieving General Chapter.

Full Text Here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.3
This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

For access to a CMC Expert Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

→ Leave a comment

Posted in manufacturing

Tagged , , ,

FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter

Posted on September 22, 2010 by admin| Leave a comment

FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter.

Full Text Here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

For A CMC Expert Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

→ Leave a comment

Posted in manufacturing

Tagged , , ,

Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

Posted on May 6, 2010 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

Full Text Here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.

This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Click Here – CMC Consulting Services – Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

ida 100programme 515x64 LowRes Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

→ Leave a comment

Posted in manufacturing

Tagged , , , , ,

Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

Posted on May 5, 2010 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

full text here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Dissolution Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Click Here – CMC Consulting Services – Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

ida 100programme 515x64 LowRes Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

→ Leave a comment

Posted in manufacturing

Tagged , , , , ,

Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

Posted on May 4, 2010 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

Full Text Hear

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.

This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Click Here – CMC Consulting Services – Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

ida 100programme 515x64 LowRes Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

→ Leave a comment

Posted in manufacturing

Tagged , , , , ,

Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

Posted on January 8, 2010 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

Full Text Here

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

First name

E-mail address

This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

ida 100programme 515x64 LowRes Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

→ Leave a comment

Posted in manufacturing

Tagged , , , , ,