Regulatory Strategy / Pre-submission Agency Communication

Pharmatech Associates has been successfully designing and deploying regulatory solutions for over 15 years. Our scientific knowledge and clinical expertise, factor into every regulatory decision we make.

We take an integrated approach by partnering with both our clients and regulatory authorities in order to drive products to the marketplace in the most efficient and compliant manner.  Our framework integrates a continuous risk management process to ensure all regulatory risks are identified and managed throughout the regulatory activity. For clients where we have the opportunity to be involved during product and process development we have the ability to define and manage program risks with the final submission in mind. Our breadth of regulatory understanding means we will identify the most appropriate regulatory strategy considering our client's strategic business and program goals. This insight can translate to both lower program risk and potentially lower program cost.

Agency communication is an integral part of the strategic planning process.  By meeting with regulatory authorities early in the development process, companies develop relationships with potential reviewers and gain valuable feedback and understanding of agency expectations specific to their product. Pharmatech's extensive experience with different branches and divisions at FDA and other regulatory agencies gives us an edge when helping clients prepare for agency meetings.