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Comprehensive Safety Reports for Regulatory Compliance

Periodic safety reports like PBRERs, DSURs, and PSURs are crucial for maintaining drug safety and regulatory compliance. Errors or omissions can lead to significant regulatory actions.

Alchemy’s Aggregate Report Writing: Accuracy and Compliance Assured

Alchemy specializes in the preparation and submission of high-quality aggregate safety reports, ensuring data accuracy, risk analysis, and adherence to regulatory timelines.

DSUR & PBRER Compilation

End-to-end support for all aggregate report types globally.

Timely Regulatory Submissions

Assured delivery within strict global timelines.

Signal Detection Integration

Reports include cumulative safety data evaluations.

Cross-Functional Collaboration

Inputs from clinical, regulatory, and safety teams harmonized.

Why Choose Alchemy for Aggregate Reports?

  • Expertise in Safety Reports – Skilled in preparing PBRERs, PSURs, DSURs, and ACOs across global markets.
  • Regulatory-Compliant Methods – Processes aligned with EMA, FDA, and local authority standards.
  • Dedicated Medical Writers – Experienced writers ensuring clarity, consistency, and compliance.
  • Audit-Ready Documentation – High-quality outputs built for regulatory review and submission.
600

PSURs/DSURs delivered

0%
On-time delivery
100%
Regulatory alignment
20

Global Clients

Testimonials

Voices of Trust

“Alchemy produced our PBRERs with exceptional attention to detail and on-time delivery.”

Calyx Pharmaceuticals

Safety Writer

“We trust them completely for DSURs—they never miss critical timelines.”

Heliogen Biotech

Aggregate Report Manager

“Their cross-functional coordination on aggregate reports is top-notch.”

Axelia Pharma

Medical Writer

“Thanks to Alchemy, our global reports passed EMA and FDA audits with no remarks.”

Feronex Life Sciences

PV Compliance Officer

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