Regulatory affairs consultants and submission support
Submission strategy, authoring, agency interaction and lifecycle maintenance, delivered by people who have done it before.
The problem we solve
Submission deadlines do not move. Your headcount does.
Regulatory workload arrives in waves: a pre-IND package, an NDA or 510(k), a wave of post-approval variations. Permanent teams are sized for the trough, so every peak turns into overtime, slipped dates or a scramble for contractors who need six weeks to learn your products.
Vakula supplies regulatory professionals who arrive already fluent in eCTD structure, agency expectations and the writing standards reviewers reward, as individual consultants or as a managed authoring team that takes the whole module.
Tell us what you need
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What we do
Regulatory Affairs capabilities
Regulatory strategy
Pathway assessment, agency meeting preparation and briefing documents for FDA, EMA, Health Canada and other authorities.
Submission authoring
Module 2 summaries, Module 3 CMC, clinical and nonclinical sections, 510(k) and De Novo content, written to agency guidance.
eCTD publishing and submission management
Compilation, hyperlinking, validation and gateway submission with a clean audit trail.
Lifecycle maintenance
Annual reports, variations, supplements, labelling updates and renewals kept on schedule.
Regulatory intelligence
Tracking guidance changes and translating them into actions for your products.
Agency response
Rapid, well-evidenced responses to information requests and deficiency letters.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
Do you handle device as well as drug submissions?
Yes. 510(k), De Novo and PMA support for devices and IVDs alongside IND, NDA, BLA and ANDA work for drugs and biologics.
Can one consultant cover both writing and publishing?
Usually not well. We typically pair a regulatory writer with a publishing specialist for submissions; for lifecycle maintenance a single experienced professional is often sufficient.
What about ex-US markets?
Our consultants have EMA, MHRA, Health Canada and selected Asia-Pacific experience. For markets where we lack depth we say so and help you find a local partner.
How are consultants engaged?
W2 contract, corp-to-corp or contract-to-hire for individuals; statement of work for managed authoring teams.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.