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John Webb Consulting Services

Helping You Gain Faster Regulatory Approvals

At John Webb Consulting Services Inc., we provide scientific and regulatory expertise in connection with the development and approval of pharmaceutical products. We are based in Canada and our focus is on the pharmaceutical quality aspects of applications to regulatory agencies. Our goal is to work with clients to minimize and avoid delays in the approval process by improving the quality of the chemistry, manufacturing and controls (CMC) part of submissions to meet the expectations of regulatory agencies. We can assess the CMC content of drug submissions early in the development process, when changes can most easily be effected or later on, closer to the filing date. We have both the scientific expertise and regulatory experience to accomplish our goals, having previously worked in Health Canada in drug submission evaluation and since that time, having helped many clients in our consulting practice.

In addition to providing assessments with respect to active ingredients and a range of dosage forms, we also specialize in inhalation/nasal products, with the associated problems relating to dose uniformity, particle/droplet size distribution and demonstration of equivalence. Applications for pressurized metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) are particularly prone to regulatory delays because of uncertainty on how to design in vitro testing protocols during product development in a way that will ultimately satisfy the regulatory agencies at the marketing approval stage. The finalization of a joint TPD/EMEA guidance for inhalation/nasal products in April 2006 should help expedite product approval in Canada for products developed in Europe. However, significant delays in Canadian approvals are likely to result for products developed in the US to meet current FDA requirements, unless important differences in the respective requirements are acknowledged and addressed during product development. Our regulatory and research experience for more than ten years with Health Canada (TPD) and extensive consulting experience in this area will serve you well.

As noted in Coopers & Lybrand's 1996 report, Pharmaceutical Industry Views: Key Issues Facing the Pharmaceutical and Biotechnology Industry, staggering losses accrue for each day the launch of a new product is delayed - for a drug with annual sales of $100 million, daily losses of $300,000 could be expected. So, if your company has ever experienced costly delays because of the CMC content in your applications to regulatory agencies, please navigate through this web site and contact us to see if we can help you avoid these problems in the future. To learn about the services we provide, see Services and for information on the educational background and professional experience of Dr. John Webb, see Information. For details on how to contact us, see Client Service .

In addition to providing you with information on our services and capabilities, it is also our intention to use this web site as a forum for commentary on regulatory issues of current interest. We will post our opinions on these issues from time to time on our News page and we welcome comments and queries from interested readers. Also, from our Download page (Downloads) you are able to download some of our conference abstracts, full-text papers or published articles on scientific regulatory issues. These files are usually provided as zipped Word Perfect and Word files; so, please pay a visit to our Downloads page.

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