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Expert in Regulatory and Labeling Strategy. Provides global pharmaceutical and biotechnology companies expert regulatory and labeling guidance and services for product registration and development. A plan to identify and map key regulatory, clinical, nonclinical, manufacturing, commercial and regional hurdles for optimal registration success. Target Product Profiles (TPP). Serves as the "road map" for current and future drug development efforts as well as eventual label for registration. Prepare submissi...

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Expert in Regulatory and Labeling Strategy. Provides global pharmaceutical and biotechnology companies expert regulatory and labeling guidance and services for product registration and development. A plan to identify and map key regulatory, clinical, nonclinical, manufacturing, commercial and regional hurdles for optimal registration success. Target Product Profiles (TPP). Serves as the road map for current and future drug development efforts as well as eventual label for registration. Prepare submissi...

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Expert in Regulatory and Labeling Strategy. Provides global pharmaceutical and biotechnology companies expert regulatory and labeling guidance and services for product registration and development. A plan to identify and map key regulatory, clinical, nonclinical, manufacturing, commercial and regional hurdles for optimal registration success. Target Product Profiles (TPP). Serves as the "road map" for current and future drug development efforts as well as eventual label for registration. Prepare submissi...

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Regulatory Strategy

http://www.proscriberx.com/Regulatory_Strategy.html

Expert in Regulatory and Labeling Strategy. A recent study by McKinsey and Co., estimated that a single day delay to market for an average drug translates into $1MM in lost revenues per day. And for a blockbuster product it equates to $5MM in lost revenues per day. Bottom-line, companies can not afford a delay of their new product approval since this results in substantial lost revenues for the company. Regulatory requirements for drug development differ across the globe. Navigates and leads companies th...

2

Target Product Profile

http://www.proscriberx.com/Target_Product_Profile.html

Expert in Regulatory and Labeling Strategy. The Target Product Profile (TPP) has become a critical communication tool with regulatory authorities, especially FDA. Beyond its use as a regulatory document, the TPP serves as the road map for current and future drug development programs and reflects the realities of the drug development program, global regulatory and clinical requirements, as well as essential components and messages for commercial development. Key elements of the TPP:. La Jolla, CA 92037.

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About Us

http://www.proscriberx.com/About.html

Expert in Regulatory and Labeling Strategy. Provides life science companies expertise to navigate the dynamic and evolving regulatory environment to successfully bring products to market. Dawn Bartizal is the President and Principal Consultant of PROscribeRx. Ms Bartizal worked extensively in the pharmaceutical industry in global product labeling and regulatory affairs before founding PROscribeRx. Over other regulatory consultancies? No matter what phase your product is in, our goal is to advance your pr...

4

Services

http://www.proscriberx.com/Services.html

Expert in Regulatory and Labeling Strategy. Provides life science companies the critical expertise to navigate the dynamic and evolving regulatory environment to bring products to market and maximize value proposition. Our expertise includes development of regulatory strategies, preparing companies for electronic regulatory requirements, post-marketing approval activities, and development of Target Product Profiles and submission labeling. Target Product Profiles (TPP). La Jolla, CA 92037.

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eRegulatory Requirements

http://www.proscriberx.com/eRegulatory_Requirements.html

Expert in Regulatory and Labeling Strategy. The pharmaceutical and biotechnology industry are required by law to manage and maintain over the course of a products life cycle a large volume of data and documents to obtain and sustain regulatory approval of a product. Electronic format is becoming the preferred and in the near future will become the mandatory. Method of submission of data and documents to regulatory authorities. Regulatory Agency Driven Electronic Initiatives:. Recognizes that preparing fo...

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Expert in Regulatory and Labeling Strategy. Provides global pharmaceutical and biotechnology companies expert regulatory and labeling guidance and services for product registration and development. A plan to identify and map key regulatory, clinical, nonclinical, manufacturing, commercial and regional hurdles for optimal registration success. Target Product Profiles (TPP). Serves as the "road map" for current and future drug development efforts as well as eventual label for registration. Prepare submissi...

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