Medical Information

Most small companies answer medical inquiries ad hoc until the ad hoc approach runs out of road

About

In a small commercial team, physician and patient inquiries usually get handled by whoever has capacity that day: a sales representative, a founder, someone in regulatory with time to spare. There is no defined ownership, no approved response content, and no consistent way to flag when a routine question is actually an adverse event or product quality complaint. This works while inquiry volume is low.

It stops working the moment you add a second market, a second product, or enough inquiry volume that inconsistent answers and missed reports become visible to a regulator or a customer. We build the function before that point, not after.

From the Trenches

Common Challenges we Solve

The Challenge

Medical Information Function Design & Governance

01

Medical Information often has no defined owner, no documented process, and no clear line to pharmacovigilance or quality. It runs on whoever picks it up that day, which works until someone asks who is accountable for what was said to a physician six months ago.

The Solution

A defined Medical Information function with clear ownership, documented process, and reporting lines into PV and quality, built to answer the accountability question before it is asked.

The Challenge

Inquiry Intake & Triage

02

A physician's question about a side effect and a genuine adverse event report sound identical on first contact. Without structured triage criteria, the person answering has no reliable way to tell them apart, and the regulatory reporting clock starts running before anyone notices.

The Solution

A single intake channel with triage criteria that flag adverse events and product quality complaints on first contact, routed into your PV and quality reporting lines within the required timeline.

The Challenge

Standard Response Documents & Response Quality

03

Without an approved reference, each person answering a medical inquiry drafts the response from memory or from whatever the last email said. The same clinical question gets a different answer depending on who takes the call, and there is no record of what was actually approved to say.

The Solution

A library of approved, evidence-referenced Standard Response Documents and FAQs, version-controlled and kept current with the product label, so response quality does not depend on who answers the phone.

The Challenge

Scaling Across Products, Markets, and Volume

04

A process built for one product in one market rarely survives a second launch or a second country. Language requirements, local reporting timelines, and rising inquiry volume expose the parts of the process that were never designed to scale, usually during the launch itself.

The Solution

A Medical Information process built with growth in mind: clear rules for when to add headcount, outsource intake, or extend the FAQ library, so scaling is a planned decision rather than a reaction to the next launch.

The Challenge

05

The Solution

The Challenge

06

The Solution

See our Other Areas of Expertise

Or contact us directly if there are any unsolved questions.

Medical Information

Building Your Commercial-Ready PV System:

The Founders

Independent pharmacovigilance leadership for small and mid-size pharma and biotech.

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Building PV systems for whatever situation put them under strain.

Stefan Brüning
Co-Founder and Consulting Practice Lead
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Responsible for leading human health and veterinary PV audits to help organisations build robust, inspection-ready PV systems.

Janine Gavin
Co-Founder and Audit Practice Lead
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“Pharmacovigilance is a fundamental responsibility to patients, not just a regulatory checkbox. We make sure your systems reflect that.”

“Solid compliance is built before the auditor knocks. We help you get there — and stay there.”