Revolution Slider Error: The param width not found in slider params.

“Failure is not an option” –US Navy SEALS

We advise biotech and drug development companies and academic groups about regulatory requirements and potential strategies for their projects. We coach teams about best practices for writing and production of clinical trial and marketing application documents. If a company does not have the experience or staff to efficiently handle all the scientific and regulatory areas needed, or the writing, we can provide access to proven experts to handle these areas, or coach the company’s internal team members to learn them. We review entire clinical trial and marketing applications for consistent message, lack of contradictory data, and to ensure applicable regulations and guidelines are met to facilitate review with minimal questions or issues from the regulatory authorities, ensuring a more efficient, timely, cost-effective process. Our frequent interactions with regulatory authorities assures their “real world” requirements are met, which are not always the same as those written in their documents or on their websites.

We also provide reliable pre- and post-marketing safety reporting to FDA including 7- and 15-day expedited safety reports, IND Development Safety Update Reports (DSURs), Risk Evaluation and Mitigation Strategy reports (REMS), 120-day Safety Updates, and Periodic Benefit-Risk Evaluation Reports (PBRERs).

Hecker & Associates provides linguistic quality control: helping non-native English speakers ensure submissions in English contain the precise nuance and content wished and are consistent with applicable regulatory guidelines and regulations. Close affiliation with expert medical writers enables us to recommend writers, or we can hire writers for you and manage their work.

For smaller companies without internal publishing groups, we can recommend and manage expert electronic submissions contractors to facilitate production of electronic clinical trial applications to FDA, and electronic marketing applications to FDA and European Agencies, both for the European Medicines Agency (EMA) and individual European Member State Regulatory Agencies, such as BfArM of Germany, or MHRA of the UK.