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P.O. Box. 888, Scotch Plains, NJ 07076

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P.O. Box. 888, Scotch Plains, NJ 07076

INTERNAL PAGES

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1

FDA

http://www.gprconline.com/index-5.html

The FDA Drug Review Process. 1 An application to begin human testing (clinical trials) of a drug is submitted to FDA. 2 FDA reviews the application to determine if it is safe to begin human testing. An Institutional Review Board (IRB) also reviews the testing plan. 3 If FDA and IRB permit, human testing begins with the purpose of determining the drug’s safety and effectiveness. 5 FDA is asked to consider approving the drug for sale in the United States. 908264.2146 gprc@gprconline.com.

2

Home

http://www.gprconline.com/index.html

GPRC Solves your CMC puzzle. Compile CMC section of the ANDA, NDA and IND application to seek US-FDA approval. Categorize and file the post approval changes to facilitate FDA approval. File the applications in paper, CTD and eCTD formats. Click here for Regulatory Support. Develop new formulation and mfg process and also trouble-shoot the approved formulation or manufacturing process under SUPAC guidance. Technology transfer, scale-up and process validation. Click here for Product Development Support.

3

Regulatory

http://www.gprconline.com/index-1.html

Provide regulatory support to develop efficient and effective strategies for the submission of new and supplemental applications including scale up and post approval changes (SUPAC) and facilitates drug approval process. Compile chemistry, manufacturing and control (CMC) section of the ANDA, NDA and IND application to seek US-FDA approval. Categorize, compile and file the post approval changes and amendments to facilitate FDA approval. Support generating in-house regulatory policies and procedures, SOPs.

4

Contact

http://www.gprconline.com/index-4.html

You can contact us on:. Generic Pharma Regulatory Consultants (GPRC). PO Box 888, Scotch Plains, NJ 07076. Dial within USA: 908.264.2146. International dial: 001.908.264.2146. Customer Service: customerservice@gprconline.com. You may also submit your questions here:. How would you like to be contacted? Both Email and Phone. How can GPRC help you? GPRC, P.O. Box. 888, Scotch Plains, NJ 07076. 908264.2146 gprc@gprconline.com.

5

Services

http://www.gprconline.com/index-3.html

Electronic Filing (eCTD) Services:. We have enterprise document management solution that does virtually everything from share, storage, manage your enterprise quickly, efficiently, reliability and most importantly, securely. We provide eCTD solution that helps to create, update, store and publish the complete set of documents. We provide eCTD solution that can be either licensed out or use as a service. GPRC provide support, recommend and assist with:. Regulatory filing to US-FDA.

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GPRC Solves your CMC puzzle. Compile CMC section of the ANDA, NDA and IND application to seek US-FDA approval. Categorize and file the post approval changes to facilitate FDA approval. File the applications in paper, CTD and eCTD formats. Click here for Regulatory Support. Develop new formulation and mfg process and also trouble-shoot the approved formulation or manufacturing process under SUPAC guidance. Technology transfer, scale-up and process validation. Click here for Product Development Support.

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