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 address all the scientific and regulatory areas needed, or the writing, we can recommend proven experts. In terms of writing, we can coach the company’s internal team members to write submission documents. We review entire clinical trial and marketing applications for consistent, sponsor-intended message, lack of contradictory data/FDA “red flags,” and ensure applicable regulations and guidelines are met to facilitate review, ensuring a more efficient, timely, cost-effective process, and as few FDA questions as possible. Our frequent interactions with regulatory authorities assures their “real world” requirements are met-- 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: we help 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 regulatory writers enables us to recommend writers, or we can hire writers for you and manage their work.

For clients without internal publishing groups, we recommend and manage expert electronic submissions contractors with whom we have worked for many years.


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