Question 1

What is regulatory consulting software?

Accepted Answer

Regulatory consulting software supports independent regulatory consultants and small consulting firms running submission work on behalf of multiple sponsor clients. Unlike sponsor or CRO software, consulting software is optimized for a smaller team (often 1-20 consultants) juggling 5-15 concurrent client engagements, with tight cost sensitivity and the need to scale from one client to many without rebuilding process. The platform supports multi-client isolation, standardized workflow templates, and client-facing read access so sponsors can see their program status without a weekly call.

Question 2

Can a solo regulatory consultant use Assyro?

Accepted Answer

Yes. Solo consultants running 3-5 concurrent client programs are a core user profile. The value proposition for solo consultants is process standardization (same workflow across every client reduces mental overhead), professional infrastructure (clients take a consultant with proper tooling more seriously than one with a SharePoint folder), and scale capacity (onboarding a 4th or 5th client doesn't linearly increase execution time). Solo consultant pricing is designed to be accessible at solo-practice scale.

Question 3

How does Assyro handle client isolation?

Accepted Answer

Each client engagement runs in a fully isolated workspace: separate documents, separate access controls, separate audit trails. Consulting staff can be assigned to multiple client engagements but the data boundaries are platform-enforced. Clients with strict confidentiality requirements (especially in biotech where IP sensitivity is high) can audit the platform's isolation controls and verify technical separation. Cross-client learnings (your workflow patterns, your standard templates) are preserved at the consultant's organizational level without exposing client-specific data.

Question 4

Can clients see their program status directly?

Accepted Answer

Yes, with scoped read access. Clients see their own programs with real-time readiness scoring, outstanding actions, and document versions. They do not see anything from your other client engagements. This changes the consultant-client relationship: instead of clients asking for status updates, clients self-serve status and reach out only when strategic input is needed. Consultants report this saves 3-5 hours per week per client just on status communication overhead.

Question 5

How does Assyro help consultants win competitive engagements?

Accepted Answer

Pharma and biotech clients increasingly evaluate consultants on execution infrastructure, not just expertise. Two consultants with equal experience — one running in Word-plus-Dropbox, one running in a proper regulatory platform — the latter wins more RFPs because the client trusts execution will be clean, audit-ready, and scalable. Consultants in Assyro's customer base report measurably higher win rates on competitive engagements once infrastructure becomes a credibility signal.

Question 6

Can consulting templates scale across clients?

Accepted Answer

Yes. Your standard IND package template, your standard 510(k) gap analysis approach, your standard briefing document format — all live as shared templates that propagate to each new client engagement while preserving client-specific content. This turns consulting delivery from bespoke-per-client into productized-plus-customization. New client onboarding goes from a week of process setup to hours, and quality consistency across engagements improves because the template encodes your best practices once.

Question 7

What submission types do consultants typically run in Assyro?

Accepted Answer

The mix depends on the consultant's specialization. Generalist regulatory consultants run the full range: INDs, 510(k)s, De Novo, NDA sections, pre-submission meeting prep, deficiency responses. CMC-specialized consultants focus on Module 3 authoring and CDMO-sponsor coordination. Device-specialized consultants run 510(k) and De Novo predicate-and-eSTAR work. Assyro covers all these, so a consultant's mix can shift over time without switching platforms.

Question 8

What happens when a client engagement ends?

Accepted Answer

Client workspaces export cleanly at engagement end: full document history, decision trail, audit log, ready for handoff to the sponsor's internal team or a successor consultant. The sponsor typically wants the regulatory history preserved even after the consultant leaves, and Assyro's export format is complete enough that the work can continue in another platform or be imported into the sponsor's internal system. Consultants reporting this workflow find it reduces end-of-engagement scramble and strengthens client relationships long-term.

Regulatory Submission Software for Consultants

Consultants Submission Workflow

Run 8 Client Programs Without a 6-Tab Spreadsheet

Deliver 3x the Client Capacity Without a 60-Hour Week

Give Every Client Their Own Audit-Ready Workspace

Turn Every Engagement Into a Productized Deliverable

Consultants Workflow Controls at Scale

Maintain Audit-Ready Submission Workflows

Manage More Consultants Programs With the Same Team Size

Questions About Consultants Workflows

See Consultants Submission Workflows in Assyro.