Frequently asked questions:

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:

•  First , the scope and quality of existing documentation used as a starting point;

•  Second , whether or not the drug substance manufacturer is preparing a Type II DMF;

•  Third , whether or not the drug product manufacturer is drafting the relevant process information;

•  Fourth , whether or not methods validation reports will be prepared by QC laboratories;

•  Fifth , whether or not QC testing laboratories will be preparing stability reports; and

•  Sixth , the quality and comprehensiveness of the documentation provided by other groups as the CMC section matures.

Can Regulatory Interlinx provide an accurate cost estimate for developing the CMC section of an IND or NDA?

Given the many variables that affect the cost and scope of preparing the CMC section of an IND or NDA, the potential costs of engaging the services of Regulatory Interlinx, Inc. can vary widely depending on its role, which can range from review and critique of documentation as it is compiled to de novo drafting of the entire CMC section, to virtually any combination in between these two extremes. Costs will therefore be determined on a case-by-base basis.

I already have in place a regulatory team. How can Regulatory Interlinx provide support to that team, and integrate into an on-going effort?

In some circumstances, in particular when the CMC effort is already well developed, a preliminary examination should be conducted in order for Regulatory Interlinx to learn more about your specific product and the state of existing documentation, as well as the role of other groups in writing portions of the CMC section. >From that point, Regulatory Interlinx can then map out a proposed scope of work for completing the CMC section of the IND or NDA. The result of this scoping exercise provides you with a road map to complete the CMC section and enables Regulatory Interlinx to provide you with a realistic budget for its further involvement in completing the CMC section of the IND or NDA.

What is the full extent of services that Regulatory Interlinx will provide?

Regulatory Interlinx has extensive in-house expertise and experience in working on FDA and international regulatory submissions, with particular expertise in the area of chemistry, manufacturing and controls. Building on this foundation, Regulatory Interlinx has also developed a large network of regulatory and compliance professionals to meet diverse client needs in all phases of drug development . Flexibility in building a team of professionals suited specifically to address your programs and concerns is our great strength. This approach of building a targeted “virtual” consulting team ensures that Regulatory Interlinx is always on top of the rapid advances in the pharmaceutical industry and changes in the regulatory

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