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No. Because our templates, eBooks, and consultant insights are digital or knowledge-based services, all sales are final and non-refundable. Once you purchase, you receive immediate access to proprietary content and expertise that cannot be “returned.” We encourage you to review all product descriptions carefully before completing your purchase.

Consultant’s Insights is an email-based service. After purchase, you’ll be able to submit your specific questions, and one of our consultants will respond via email with tailored insight and commentary. This service does not automatically include calls or meetings. If you need a live call or more extensive interaction, that must be arranged separately and will involve additional cost.

Our templates are designed to be versatile and generally applicable across a wide range of FDA-related scenarios, including cosmetics label reviews, medical device label reviews, 510(k) submissions, pre-submissions, and more. While they provide a strong, structured starting point, you will still need to tailor them to your specific product, indication, and regulatory path. Purchasing a template does not include custom editing or project work.

Yes. Consultant’s Insights is intended for focused questions that can be reasonably addressed via email. If your query requires a highly detailed, multi-hour analysis, extensive document review, or ongoing back-and-forth, additional charges may apply. In cases where your request moves beyond insight and into actual project work (e.g., drafting submissions, writing sections, or managing strategy), we will outline a separate proposal and fee structure before proceeding.

Our eBooks are educational resources that break down complex FDA requirements into plain language. They include real-life case studies of what went wrong, what went well, and common mistakes to avoid. Unlike templates—which are fillable, structured documents—eBooks focus on understanding: context, strategy, patterns, and lessons learned from actual regulatory situations.

If, during our email exchange, it becomes clear that your needs go beyond high-level insight—for example, you need us to prepare documents, conduct detailed gap analyses, or participate in strategic planning—our service will transition and propose a separate project scope, timeline, and fee. Similarly, if you would like a phone or video call, that must be arranged separately and will incur an additional fee. We will always inform you and get your approval before any extra charges are incurred.