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Regulatory Interlinx, Inc.

Regulatory Interlinx, Inc. provides expert advice on pharmaceutical development and drug approval. Our staff has extensive experience working on FDA and international regulatory submissions, with particular expertise in the area of chemistry, manufacturing and controls (CMC).

http://www.regulatoryinterlinx.com/

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Regulatory Interlinx, Inc. | regulatoryinterlinx.com Reviews

https://regulatoryinterlinx.com

Regulatory Interlinx, Inc. provides expert advice on pharmaceutical development and drug approval. Our staff has extensive experience working on FDA and international regulatory submissions, with particular expertise in the area of chemistry, manufacturing and controls (CMC).

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1

Links - Regulatory Interlinx

http://www.regulatoryinterlinx.com/links

Food and Drug Administration (Home Page). Http:/ www.fda.gov. FDA Center for Drug Evaluation and Research. Http:/ www.fda.gov/cder/. Http:/ www.fda.gov/cder/guidance/index.htm. Http:/ www.fda.gov/cder/warn/. Http:/ www.fda.gov/oc/enforcement.html#Warning. Code of Federal Regulations (CFR). Http:/ www.access.gpo.gov/cgi-bin/cfrassemble.cgi? Http:/ www.usp.org/. Regulatory Affairs Professionals Society (RAPS). Https:/ www.raps.org/s raps/alias.asp. Http:/ www.ibdprince.com/metric.shtml.

2

Values behind Regulatory Interlinx Service

http://www.regulatoryinterlinx.com/values

We are fully committed to providing to each and every client the highest possible quality in all of our consulting services. Our experience in academia, at FDA and in industry ensures that you receive the most insightful, targeted and cutting-edge expert CMC advice during all phases of drug development. Timely product delivery is critical to meeting your development schedule and deadlines. We are sensitive to your needs, and we not only deliver quality products tailored for you, we deliver on time.

3

Regulatory Interlinx, Inc.

http://www.regulatoryinterlinx.com/index.php

Regulatory Interlinx, Inc. provides expert advice on pharmaceutical development and drug approval. Our staff has extensive experience working on FDA and international regulatory submissions, with particular expertise in the area of chemistry, manufacturing and controls (CMC). REGULATORY INTERLINX, INC.

4

Do It Right with Regulatory Interlinx

http://www.regulatoryinterlinx.com/doitright

Do it Right the First Time. We help you streamline and implement the best possible CMC development program. With our expert advice, you can minimize your time to submission by ensuring from the start that studies and documents are completed and prepared properly. We prepare targeted, focused, and clearly understood regulatory documents that are expertly packaged for FDA review. Write Concise FDA Submissions. Implement Effective Development Strategies. Strengthen Your Regulatory Team. Rely on us to develo...

5

FAQ - Regulatory Interlinx

http://www.regulatoryinterlinx.com/faq

What are the primary factors affecting the cost and scope of preparing the CMC section of an IND or NDA? The costs of preparing the CMC section of the NDA are affected most by six related factors:. The scope and quality of existing documentation used as a starting point;. Whether or not the drug substance manufacturer is preparing a Type II DMF;. Whether or not the drug product manufacturer is drafting the relevant process information;. I already have in place a regulatory team. How can Regulatory In...

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Regulatory Interlinx, Inc. provides expert advice on pharmaceutical development and drug approval. Our staff has extensive experience working on FDA and international regulatory submissions, with particular expertise in the area of chemistry, manufacturing and controls (CMC). REGULATORY INTERLINX, INC.

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