Regulatory Strategy / Pre-submission Agency Communication

Pharmatech Associates has been successfully designing and deploying regulatory solutions for over 20 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 evaluates any regulatory risks that may arise and help our clients control them in order to avoid costly errors.  Understanding a company’s business goals, coupled with our knowledge and experience of global regulatory requirements, means lower cost and preparation time through the creation of forward looking regulatory strategies which avoid redundant activities and incorporate the unique considerations that are essential to a successful filing.

Pre-submission agency communication is often an integral part of the strategic planning process.  By meeting with regulatory authorities early in the development process, companies gain valuable feedback and understanding of agency expectations specific to their product.