Generic Drug Makers Editing and Proofreading Services

A generic medicine has to be the same as the original in every way that matters and different in one way that is entirely legal: it may not claim the indications still under patent. So the labelling is carved. Sections are removed, sentences are trimmed, and what remains must still be a complete and safe document for a prescriber who will never see the version it came from.

We edit what generic manufacturers and their regulatory teams produce — labelling and package leaflet comparisons against the reference product, carve-out justifications and their supporting rationale, bioequivalence study reports and their summaries, abbreviated and generic marketing applications, quality and manufacturing documentation for submissions, responses to regulatory deficiency questions, labelling update tracking against reference product changes, patient leaflet readability documentation, pharmacovigilance system documentation, and prescriber and pharmacy-facing product information. Our editors work on the document created by removing things.

The labelling comparison and carve-out justification is where generic submissions succeed or attract questions, and its failure is presenting the result rather than the operation. A carved label submitted alongside the reference label leaves the assessor to find the differences and infer the reasoning. We work through these so every difference is listed as a difference, with the reference wording, the proposed wording and the reason, since an assessor who has to diff two documents themselves will find the one you did not intend; so each carve-out is tied to the specific protected indication or exclusivity it relates to, because a removal justified by reference to patents generally is not a justification; so the safety consequence of every removal is addressed explicitly, given that a carved indication frequently carries warnings, interactions or dosing information that apply to the retained indications too and deleting them wholesale is the classic error; so any wording that had to be adjusted rather than deleted is flagged, as changed text hides more easily than absent text; so the position on off-label use of the carved indication is stated rather than left implicit; and so the tracking mechanism for future reference product changes is described, since the reference label will move and the carve-out has to move with it. Submissions written this way get through with fewer cycles.

Everything you send is treated in confidence, including submissions, labelling and commercial information. We are editors rather than regulatory, legal or clinical advisers, and we offer no view on carve-outs, patents or labelling requirements. What we can do is make every difference visible and explained.