Multiple research authorities
FDA, HHS, OHRP, IRB-related, institutional and state sources may govern different studies and activities.
RegWatch for Biotechnology & Clinical Research
Stay ahead of biotechnology and clinical research regulatory change.
Track the clinical trial, human-subject protection, FDA, laboratory practice, biosafety, research security, privacy, reporting and state life-science requirements your organization selects. RegWatch organizes change for research and quality teams.
No credit card required for the free monitoring account.
Regulatory change command center
Clinical TrialsHuman SubjectsFDAGood Clinical PracticeLaboratory PracticesBiosafetyResearch SecurityPrivacy
Why RegWatch
Research oversight follows the study, institution and product lifecycle.
Biotechnology and research organizations may follow FDA, HHS and OHRP materials, institutional requirements, laboratory and biosafety sources, privacy rules and state obligations. RegWatch organizes selected monitoring.
Study-specific obligations
Requirements can vary by product, protocol, sponsor role, research site, data type and participant population.
Safety and reporting timelines
Clinical safety, protocol, incident and oversight updates can require rapid routing to defined owners.
Research data and security
Privacy, cybersecurity, biosafety and research-security changes may involve science, compliance, IT and legal teams.
Monitoring Coverage
Build a watchlist around how your organization actually operates.
Build monitoring around your products, studies, sponsor responsibilities, research sites and selected jurisdictions.
Clinical trials and GCP
Selected FDA clinical trial, Good Clinical Practice, investigator, sponsor and study-conduct materials.
Human-subject protections
HHS, OHRP, Common Rule, IRB, informed-consent and research-participant protection sources.
FDA product-development requirements
Selected IND, IDE, biologic, drug, device, safety-reporting and related development materials.
Laboratory and biosafety practices
Selected laboratory quality, good laboratory practice, biosafety and biological-material requirements.
Research security and privacy
Data privacy, cybersecurity, research security, access, transfer and incident-related sources.
Reporting and state life-science rules
Safety, registration, transparency, state research and other selected life-science reporting requirements.
Monitor availability and applicability vary by source, jurisdiction and organization. Your team chooses the watchlist it wants RegWatch to follow.
How RegWatch Works
Move from “something changed” to a focused review process.
Select your monitors, receive organized change intelligence and optionally connect policies for assessment.
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1
Select your monitors
Choose the agencies, regulations, standards, licensing sources and jurisdictions relevant to your operations.
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2
Review focused change summaries
See what changed, important dates, affected requirements, source links and suggested review areas.
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3
Connect policies when useful
Upload and assign clinical, quality, human-subject, biosafety, privacy or research-security policies or procedures to the monitors they support.
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4
Assess gaps and document action
Review potential policy gaps, ownership, next steps, review activity and supporting evidence in a consistent workflow.
Illustrative workflow
New Update
A change is detected. Your team sees the context.
1
Monitor
Selected source
Actively monitoring
RegWatch follows the rule, bulletin, manual, guidance or licensing source your team selects.
2
Detect
Change identified
Change Alert Detected
Biotechnology & Research Update
New
+
Requirement updated
Source captured and compared with the previous version.
The update is captured, summarized and organized so reviewers can focus on what changed.
3
Review
Context delivered
RegWatch Review
Ready for your team
Ready
SummaryWhat changed
Key datesWhen it matters
PoliciesWhat to review
Next stepsWho owns action
Assigned to compliance, IT and legal reviewers
Your team receives a focused review package instead of another unstructured alert.
Built for Biotechnology & Clinical Research
One monitoring approach across studies and research functions.
RegWatch can support organizations with different products, protocols, sponsor roles, research sites and jurisdictions while preserving study-relevant watchlists.
Create your free monitoring accountBiotechnology companiesClinical research organizationsDrug and biologic sponsorsMedical device research teamsAcademic research institutionsMulti-site clinical trial programs
What Your Team Gains
A more manageable way to stay aware, assess impact and document follow-through.
Less manual monitoring
Reduce repeated searches across individual regulator, program and jurisdiction websites.
More focused reviews
Give owners the source, dates, affected topics and review context in one place.
Better policy alignment
Connect selected requirements with the policies and procedures your team relies on.
A clearer audit trail
Keep updates, assessments, review activity and supporting evidence organized.
Frequently Asked Questions
Research regulatory monitoring with focused review context.
Start with regulatory monitoring, then add optional policy assessment workflows when your team is ready.
Talk to AllgressWhich biotechnology and research requirements can RegWatch monitor?
Organizations can select relevant clinical trial, human-subject protection, FDA, laboratory practice, biosafety, research security, privacy, reporting and state life-science sources. Available coverage depends on selected monitors and sources.
Can different studies use separate watchlists?
Yes. Watchlists can reflect product type, protocol, sponsor role, research site, participant population, data and jurisdiction.
Are protocol or policy uploads required?
No. Monitoring can be used without uploading documents. Uploads are optional and may support document assessment workflows.
How can RegWatch support research-policy review?
Assign uploaded clinical, quality, human-subject, biosafety, privacy or research-security documents to selected monitors. RegWatch can identify areas that may require review when sources change.
Does RegWatch replace an IRB, regulatory affairs team or counsel?
No. RegWatch provides regulatory intelligence and workflow support. It does not make protocol, applicability, ethical or legal determinations.
Start with the sources that matter to you
Make life-science regulatory monitoring easier to manage.
Get a free RegWatch account and begin building the monitoring watchlist your biotechnology & clinical research team needs.