Industries/ Prescription Drugs

Prescription Drug
Adverse Event Management

Pharmacovigilance services for prescription drug companies, backed by licensed medical professionals, 24/7 availability, and direct FDA Gateway submission capability.

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Why prescription drug companies work with us

Licensed clinical review on every case, not just regulatory coordination.

Prescription drug pharmacovigilance involves a combination of expedited ICSR reporting, periodic safety update obligations, and global literature surveillance that mid-market manufacturers frequently underestimate operationally. When a serious adverse drug reaction is reported, your process needs to be fast, clinically sound, and documented to withstand regulatory scrutiny.

Our team routinely includes pharmacists and nurses who assess causality, apply MedDRA coding, and prepare ICSR submissions directly to the FDA Gateway. For manufacturers distributing in Canada, we also manage Health Canada MHPD reporting obligations.

Whether you are building a pharmacovigilance program for the first time or strengthening an existing one, we can help you build a system that meets your regulatory obligations and holds up under audit.

Licensed Clinical Review

Every case is evaluated by a licensed medical professional, not a regulatory coordinator. That clinical judgment is what makes your documentation defensible.

FDA Gateway Submissions

We prepare and submit ICSRs directly through the FDA Gateway with MedDRA coding, so your reports meet FDA’s technical requirements every time.

24/7 Serious Report Intake

Our medical contact center operates around the clock so no serious report is missed or delayed.

Health Canada Reporting

For manufacturers distributing in Canada, we manage Health Canada MHPD reporting obligations alongside FDA submissions under one program.

Prescription drug capabilities

A complete pharmacovigilance workflow, documented in a validated database.

Expedited ICSR Reporting
Periodic Reports (PADERs)
MedDRA Coding
FDA Gateway & Health Canada
Audit-Ready Documentation

Expedited ICSR Reporting

Under 21 CFR 314.80, Marketing Authorization holders are required to submit expedited reports to the FDA for serious, unexpected adverse drug reactions within 15 calendar days of becoming aware. SafetyCall manages this process end to end: our licensed clinicians review each case, apply the appropriate seriousness and expectedness assessment, prepare the Individual Case Safety Report in the required format, and submit directly through the FDA Gateway. Every submission is documented with a complete audit trail in our 21 CFR Part 11-validated SafetyNotes database.

Periodic Reports (PADERs)

In addition to expedited reporting, prescription drug companies are required to submit periodic summaries of all adverse drug experience information received during defined reporting intervals. SafetyCall supports PADER preparation by aggregating your adverse event data across the reporting period, applying the clinical analyses as required, and working with your regulatory team to prepare the final submission. This structured review also provides an opportunity to identify emerging safety signals before they require escalated attention.

MedDRA Coding

Accurate MedDRA coding is foundational to both regulatory submissions and signal detection. Inconsistent coding creates gaps in your safety database that can complicate FDA submissions and obscure emerging patterns in your adverse event data. SafetyCall applies standardized MedDRA terminology to every case, reviewed by licensed medical professionals who understand both the clinical context and the regulatory implications of coding decisions. This consistency supports cleaner data, more reliable trend analysis, and stronger documentation for audits and inspections.

FDA Gateway & Health Canada

SafetyCall manages regulatory submissions to both the FDA and Health Canada’s Marketed Health Products Directorate (MHPD) for prescription drug companies with cross-border distribution obligations. Our team is experienced in the technical and formatting requirements for each agency, including submission through the FDA Gateway and Health Canada’s reporting formats, so your submissions meet the standards each authority expects.

Audit-Ready Documentation

Every adverse event managed through SafetyCall is documented in our validated SafetyNotes database, which meets FDA’s 21 CFR Part 11 requirements for electronic records and signatures. Each record includes timestamped intake, case notes, coding, and submission confirmations, creating a complete chain of documentation that holds up under regulatory audit. For prescription drug companies, this level of documentation is not just a compliance requirement: it is your primary defense in the event of an FDA inspection or product liability proceeding.

REGULATORY FRAMEWORK FOR PRESCRIPTION DRUGS

What the rules actually require of you.

US prescription drug manufacturers report adverse events under two federal frameworks. The obligations differ by approval status, but both demand a systematic process for receiving, evaluating, documenting, and reporting adverse drug experiences to the FDA.

21 CFR 314.80

Marketing authorization holders

Post-marketing safety reporting for approved drug applications, covering expedited and periodic adverse experience reports.

21 CFR 310.305

Marketed drugs without approved applications

Reporting obligations for manufacturers and distributors of marketed drugs not subject to an approved application. Both frameworks require systematic processes for receiving, evaluating, documenting, and reporting adverse drug experiences to the FDA.

The expedited reporting window

Serious and unexpected adverse drug reactions must be reported to the FDA within fifteen calendar days of awareness. A serious adverse drug experience includes any of the following outcomes.

Death

Inpatient hospitalization

Congenital anomaly

A life-threatening experience

Persistent or significant disability

Medical or surgical intervention

Causality is not a prerequisite for reporting.

Health Canada · MHPD

Marketed Health Products Directorate

For prescription drug manufacturers with distribution in Canada, the Marketed Health Products Directorate (MHPD) imposes reporting obligations that must be managed alongside FDA requirements. The core framework is similar, but submission formats, timelines, and agency expectations differ. Companies expanding into, or already selling in, Canada should confirm that their adverse event program accounts for MHPD obligations from the outset.

Related Industries

Adverse event management for adjacent product categories.

OTC Drugs

Non-prescription drug AE management.

Learn More About OTC Drugs

Medical Devices

MDR Reporting and post-market surveillance

Learn More About Medical Devices

Medical Cannabis & CBD

AE management for cannabis-derived products.

Learn More About Medical Cannabis & CBD

Frequently Asked Questions

What does SafetyCall's ICSR submission process look like for prescription drug manufacturers?

When a serious adverse drug experience is reported, SafetyCall handles the end-to-end process: licensed medical professional review, MedDRA coding, ICSR preparation, and direct submission through the FDA Gateway. Product and reporter information is provided through our intake process; we manage everything from clinical evaluation through submission. Every record is timestamped and stored in our 21 CFR Part 11-validated SafetyNotes database, giving you a complete, inspection-ready documentation trail.

How does SafetyCall support Periodic Adverse Drug Experience Report (PADER) obligations?

SafetyCall can support PADER preparation by aggregating and analyzing your adverse event data over the applicable reporting period, applying the clinical and regulatory review required, and preparing the report for FDA submission. We work with your regulatory team throughout the process so the final document reflects your program’s safety profile accurately. Please contact us to discuss how PADER support fits within your program.

Does SafetyCall handle Health Canada reporting for manufacturers distributing in Canada?

Yes. For prescription drug manufacturers with Canadian distribution obligations, SafetyCall manages Health Canada Marketed Health Products Directorate (MHPD) reporting. Our team is familiar with Health Canada’s reporting requirements and submission formats, so you have consistent clinical oversight and documentation.

Prescription DrugAdverse Event Management