The problem
Most regulatory work happens after approval.
An approved application keeps generating work: supplements for manufacturing and labelling changes, annual reports, responses to agency correspondence and commitments that have to be tracked to closure. Every change has to be filed in the right reporting category, with the right supporting data, at the right time.
A change reported in an annual report that should have been a prior approval supplement is a compliance finding, not a paperwork slip. Getting the category right is judgement, and it needs someone who understands the chemistry, manufacturing and controls behind the change.
For a lean regulatory team the volume is usually the problem, not the complexity. We take on the volume, from change assessment and authoring to publishing and tracking, so your own people can work on the submissions that move the business.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we deliver.
Investigational applications
IND preparation and maintenance: protocol amendments, information amendments, safety reports and annual reports.
What that means for you
- Amendments filed in the right category
- Annual reports on time
- A clear record of what was sent and when
Post-approval changes
Change assessment against FDA reporting categories: prior approval supplements, changes being effected supplements (CBE-30 and CBE-0) and annual report changes.
What that means for you
- Each change categorised with a written rationale
- Supporting data requested before it is needed
- Fewer surprises at inspection
NDA, ANDA and BLA authoring
Regional Module 1 documents, Module 2 summaries and Module 3 quality documentation, written to read as one file.
What that means for you
- Authors who understand the CMC behind the words
- Consistency across modules
- Deficiency responses handled by the same team
eCTD publishing
Compilation, technical validation and lifecycle management of eCTD sequences, ready for submission through your FDA Electronic Submissions Gateway account.
What that means for you
- Technical validation before anything is sent
- A clean sequence history
- A planned move to eCTD v4.0 when it suits you
Engagement write-ups appear here only once the client concerned has approved the wording in writing.We do not publish client names or outcomes without that approval.
How it runs
How lifecycle support runs.
Portfolio intake
Applications, open commitments and upcoming due dates collected in one register.
Change and submission plan
Each change categorised and each submission scheduled, with owners and data needs.
Authoring and publishing
Documents written or reviewed, compiled into eCTD sequences and validated.
Tracking and correspondence
Submissions, agency letters and commitments tracked until they are closed.
Questions
Questions we get asked before the first call.
Which submissions must be in eCTD format?
FDA requires eCTD format for NDAs, ANDAs and BLAs, including their supplements and amendments, and for commercial INDs and master files. eCTD is optional, though encouraged, for noncommercial INDs, Type III master files and submissions for blood and blood components. We confirm the requirement for your specific submission before we start.
Should we move to eCTD v4.0 now?
Not necessarily. FDA accepts eCTD v4.0 for new applications on a voluntary basis and still supports version 3.2.2, and has said it will give advance notice before v4.0 becomes the only option. We plan the move with you rather than forcing it.
Can you take over an application mid-lifecycle?
Yes. We start by reconciling the sequence history and the commitments on file, so nothing already promised to FDA is lost in the handover.
Do you publish submissions written by others?
Yes. Publishing-only engagements are common. We flag content issues we notice, but we do not rewrite your documents unless you ask.
Do you support biologics?
Yes, including BLA lifecycle work and CMC changes. Comparability questions for biologics need input from your process scientists, so we plan for that early.
Related
Where to go next.
Pharmacovigilance
Case processing and periodic safety reporting alongside the application.
Read more ›Labelling & regulatory intelligence
Label changes and new requirements, assessed and actioned.
Read more ›A backlog of supplements or annual reports?
Send us the list. A specialist replies with how we would clear it and in what order.