Regulatory affairs workflow software

Regulatory affairs workflow software that makes compliance operational

Q: What is regulatory affairs workflow software?

It's a platform that helps regulatory teams run and track compliance-related tasks and submissions with precision and visibility.

Q: How does Process Street help regulatory teams?

We automate workflows, track execution, and ensure all steps are completed and documented for compliance or audit purposes.

Q: Can it help with FDA or EMA filings?

Yes. You can create region-specific workflows and adapt templates to meet submission requirements for any health authority.

Q: Does it support cross-functional coordination?

Yes. RA, QA, legal, and other teams can collaborate in shared workflows with clear ownership and status tracking.

Q: Is it secure and audit-ready?

Yes. We support SOC 2, ISO 27001, and provide time-stamped logs, version control, and access permissions.

Q: How fast can we launch?

Most teams go live in days using our templates and guided onboarding.

Standardize submissions, manage documentation, and track approvals with Process Street. The regulatory affairs workflow software built for precision, traceability, and speed.

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Process Street Regulatory Affairs Workflow Software

Trusted by more than 3000 companies

What's your biggest regulatory operations challenge?

Use workflows to manage timelines, track status, and assign ownership for every regulatory submission.

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Regulatory success depends on more than compliance. It depends on execution. Whether you're submitting to the FDA, EMA, or internal regulators, every detail, deadline, and document must be managed without error.

Process Street is regulatory affairs workflow software that turns complex requirements into trackable, auditable processes. Standardize execution and never miss a step.

Run submission and approval workflows

Assign owners, track timelines, and document every step from creation to approval and submission.

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Manage regulatory documentation

Tie labeling, SOPs, study data, and supporting files directly to the workflow that manages them.

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Track tasks and deadlines

Set due dates, assign roles, and follow up with automated notifications so nothing slips through the cracks.

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Enforce regulatory SOPs

Ensure all processes follow internal and external guidance with workflows that require completion before approval.

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Meet Cora,
your regulatory process watchdog

Cora monitors workflow execution, flags missed steps, and helps improve accuracy across submissions and compliance tasks.

Builds and refines regulatory workflows Use AI to create, review, and optimize your SOPs and process flows
Tracks status and completion in real time Know where each filing stands and who's responsible
Flags gaps before they impact approval Identify missing documentation or overdue actions instantly
Surfaces opportunities to improve Use workflow data to reduce delays and prevent compliance issues

With Cora, your regulatory workflows become predictable, traceable, and inspection ready.

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Automate filing and submission prep

Use templates to guide your team through dossier compilation, QC, and final submission packaging.

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Coordinate cross-functional work

Collaborate across RA, QA, legal, and operations using shared workflows and checklists.

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Maintain audit trails automatically

Capture time-stamped task completion, document uploads, and sign-offs for every step.

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Support regional and global submissions

Adapt templates for FDA, EMA, MHRA, and other health authorities with built-in flexibility.

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Regulatory affairs teams use Process Street's regulatory workflow software to manage submissions, prove compliance, and improve team performance:

Regulatory submissions

Track ownership, documentation, and timelines from draft to delivery.

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Labeling reviews and approvals

Route changes, collect approvals, and log documentation with version control.

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SOP enforcement

Tie internal processes directly to workflows that enforce every step.

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Audit and inspection readiness

Generate reports, proof, and timelines automatically from completed workflows.

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Cross-functional compliance

Coordinate work across departments with clear roles and documented outcomes.

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Training and policy rollouts

Push updated policies and track acknowledgment across teams, sites, or functions.

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Frequently asked questions

Can't find the answer you need? Contact our support team.

What is regulatory affairs workflow software?

How does Process Street help regulatory teams?

Can it help with FDA or EMA filings?

Does it support cross-functional coordination?

Is it secure and audit-ready?

How fast can we launch?

Trusted by 3000+ Companies

From life sciences to consumer goods, Process Street powers regulatory affairs workflow software that keeps compliance running on time.

Data protection & security

ISO27001 compliance

Process Street is ISO 27001 certified, confirming compliance with global standards and a strong commitment to protecting customer data through audited, continuously monitored security controls.

Data protection & security

SOC 2 Type II compliance

Process Street has passed a SOC 2 Type II audit, confirming that it meets various criteria for safeguarding customer data. An independent external auditor has verified the effectiveness of the controls implemented by Process Street.

Healthcare information privacy

HIPAA compliance

HIPAA, a federal law, safeguards patient health information. Process Street's robust security measures include the option for a Business Associate Agreement upon request, ensuring HIPAA compliance.

Data protection & security

AWS CIS compliance

The CIS AWS Foundations Benchmark provides security best practices for AWS environments. Process Street's compliance ensures a secure cloud infrastructure by following established guidelines for configuration and monitoring.

EU Data protection & privacy

GDPR compliance

The General Data Protection Regulation (GDPR) is an EU law designed to protect the privacy of individuals and businesses in the EU economic area. It establishes rules for how personal data is collected and handled. Read our GDPR statement

Data protection & privacy

CCPA compliance

The California Consumer Privacy Act (CCPA) gives California residents more control over their personal data, including rights to access, delete, and opt out of data sales. Process Street ensures compliance through transparent practices.

Security & privacy

Artificial intelligence

Your data is never used to train AI models. Any data read or created by a workflow is exclusive to that particular workflow instance and cannot be accessed otherwise, even from within the same organization.

Data sovereignty & infrastructure

Data residency & private cloud

Choose where your data is stored with support for US, UK, Canada, EU, and UAE regions. Customers can also opt for private cloud deployment in their own VPC for maximum control and security.