What gets challenged and where
Regulatory litigation usually means asking a court to review what an agency did, or defending a company when an agency goes to court against it. Federal rules and orders are typically challenged under the Administrative Procedure Act, sometimes in a district court and sometimes directly in a court of appeals, depending on the statute involved. In New York, state and local agency decisions are commonly reviewed through an Article 78 proceeding, which has a very short filing window. The forum is not always a free choice, and filing in the wrong place can cost time that cannot be recovered. Federal courts no longer defer to an agency's reading of an ambiguous statute the way they once did, which has changed how many of these cases are argued, although agency fact-finding still receives considerable respect.
The record decides most of it
Review of agency action is usually confined to the administrative record, meaning the material that was before the agency when it decided. That makes the comments you filed, the documents you submitted, and the objections you raised during the agency process far more important than new evidence gathered later. Courts often decline to hear arguments a party never presented to the agency, and many regulatory schemes require you to use internal appeals before going to court. If a proceeding is still open, the most useful work may be building that record now. Keep the notices, your submissions, the agency's responses, and any correspondence that shows what the agency knew and when.
Deciding whether to sue
Not every adverse decision is worth a lawsuit. A court that agrees with you often sends the matter back to the agency rather than ordering the result you wanted, and the agency may reach a similar decision through a better process. On the other hand, a rule left unchallenged can shape your industry for a long time. Early on we test whether the action is final and reviewable, which court has jurisdiction, what deadline applies, and whether interim relief such as a stay is realistic. We also consider whether a trade association or other companies share the interest, since standing and cost are often easier to manage together.