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ProReg Resources

Specializing in regulatory affairs project management and in strategic planning for global Chemistry, Manufacturing, and Controls documentation for all phases of drug development. Our goal is to ensure that all. We specialize in coordinating regulatory strategies that maximize your chances for success with regulatory agencies around the world. Have a strategy in place but just need the manpower to prepare your submission documents? Then look at our. To make your possibilities a reality. ProReg Resources,...

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ProReg Resources | proregresources.com Reviews
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Specializing in regulatory affairs project management and in strategic planning for global Chemistry, Manufacturing, and Controls documentation for all phases of drug development. Our goal is to ensure that all. We specialize in coordinating regulatory strategies that maximize your chances for success with regulatory agencies around the world. Have a strategy in place but just need the manpower to prepare your submission documents? Then look at our. To make your possibilities a reality. ProReg Resources,...
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1 proreg resources
2 about us
3 services
4 resources
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6 members of
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8 biostat consultants
9 ken king consulting
10 michigan cmc alliance
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ProReg Resources | proregresources.com Reviews

https://proregresources.com

Specializing in regulatory affairs project management and in strategic planning for global Chemistry, Manufacturing, and Controls documentation for all phases of drug development. Our goal is to ensure that all. We specialize in coordinating regulatory strategies that maximize your chances for success with regulatory agencies around the world. Have a strategy in place but just need the manpower to prepare your submission documents? Then look at our. To make your possibilities a reality. ProReg Resources,...

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Resources

http://www.proregresources.com/id61.html

Below are links to some sites we think you might find useful. Links to Agency Regulations for the Pharmaceutical Industry. FDA Center for Drug Evaluation and Research. FDA Center for Biologics Evaluation and Research. FDA Center for Veterinary Medicine. Code of Federal Regulations. International Conference on Harmonisation. The Rules Governing Medicinal Products in the European Union. European Guidelines on Quality, Safety, and Efficacy. The UK Medicines Control Agency. Powered by Register.com.

2

About Us

http://www.proregresources.com/id1.html

Our partners have a combined total of 46 years of experience in the pharmaceutical industry, including:. Bull; 30 years providing regulatory guidance to pharmaceutical development teams and preparing global CMC documentation for both human and animal health drug applications. Bull; 30 years participation on regulatory affairs project teams. Bull; Experienced in all phases of document preparation, including INDs, CTAs, NDAs, ANDAs, NADAs, MAAs, and rest-of-world submissions, including post-approval support.

3

Services

http://www.proregresources.com/id4.html

All services are provided with the utmost concern for high quality and customer expectations. These services include, but are not limited to the following:. Preparation for and participation in regulatory agencies meetings. Strategic planning and risk assessment for CMC regulatory submissions. Investigational New Drug (IND) Applications. Clinical Trial Applications (CTAs). US New Drug Applications (NDAs). US Abbreviated New Drug Applications (ANDA). EU Marketing Authorization Applications (MAAs).

4

Contact Us

http://www.proregresources.com/id5.html

To request our assistance, or for additional information on our regulatory affairs services, please contact us. Call us directly at 269-372-2911, or just send an email to. Thank you for visiting our web site. Powered by Register.com.

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ProReg Resources

Specializing in regulatory affairs project management and in strategic planning for global Chemistry, Manufacturing, and Controls documentation for all phases of drug development. Our goal is to ensure that all. We specialize in coordinating regulatory strategies that maximize your chances for success with regulatory agencies around the world. Have a strategy in place but just need the manpower to prepare your submission documents? Then look at our. To make your possibilities a reality. ProReg Resources,...

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