The grounds for refusal are documentary
The regulation lists what a refuse to file decision can rest on, and several of the grounds are about the document rather than the drug. An application may be refused because it is not submitted on the required form or in the required format, or because it is incomplete on its face. It may also be refused for lacking an environmental assessment or a claim of categorical exclusion, or because portions in another language arrive without an English translation.1
The last of those is worth reading twice. A complete, well-conducted study reported in a language other than English, submitted without the accurate and complete translation the regulation requires, is a filing failure rather than a scientific one.2
The contents and the order are both specified
An application has a required shape. The regulation names the application form, the index, the summary, the technical sections, the pediatric use section, case report forms and tabulations, and samples and labeling. The technical sections are themselves enumerated: chemistry, manufacturing, and controls; nonclinical pharmacology and toxicology; human pharmacokinetics and bioavailability; microbiology; clinical data; and statistics.2
The index is a requirement in its own right. The archival copy must contain a comprehensive index by volume number and page number to the summary, the technical sections, and the supporting information.2 A submission whose index does not match its own pagination has a defect that a reviewer meets before meeting anything else.
The regulation also requires that separate copies be assembled differently, with the review copy carrying each technical section separately bound alongside the application form and the summary.2 Assembly is part of the specification, not a courtesy.
What that leaves for an editor, and why it is a large job
None of the work below requires a view about the pharmacology.
Cross-references and pagination come first, because they are the last things to break. A submission reordered late has an index pointing at the wrong volumes, and the index is what the regulation requires to be comprehensive.2
Terminology comes second. A compound, a study, an endpoint, or an adverse event named three ways across six technical sections written by different groups is three things to a reader who did not attend the meetings. Editors Canada places that work inside copy editing, which covers checking for and correcting errors and inconsistencies and checking mechanical consistency.3
Numeric agreement comes third. A figure in a summary that does not match the figure in the technical section it summarizes is not a rounding question to a reviewer. It is a discrepancy, and the summary is the part read first.
Translated material comes fourth, and it needs the same consistency check as everything else. The requirement is for an accurate and complete translation of each part not in English, which means the translation carries the document's terminology decisions too.2
The division of labor that makes this work
The Editorial Freelancers Association describes copyediting as correcting spelling, grammar, usage, and punctuation, checking cross-references, and preparing the style sheets that guide consistency and accuracy across a manuscript.4 On a regulatory submission that style sheet is the most valuable single artifact, because the submission is written by many hands over years and the style sheet is the only place the decisions live.
What an editor does not do is decide what a result means, whether an endpoint was appropriate, whether a study supports a claim, or whether the labeling is correct. Those determinations belong to the sponsor and its regulatory, medical, and statistical reviewers, and they arrive with the copy. An editor who altered a defined term to read better would have changed a claim.
Everything a client sends is treated in confidence, including study reports, unpublished data, and correspondence with an agency. EditFast works on regulatory submissions and on technical manuals against whatever specification the sponsor supplies.
Sponsors who commission the consistency pass before the internal review usually get a shorter internal review. The alternative is discovering the terminology problem in the sixty-day window, when nothing can be reassembled in time.