Reduce repetitive information work
Assign preparation, editing and checking tasks to medpharmtec. Receive the documents and findings your team needs without reconstructing what was changed, checked or left unresolved.
Regulatory Labeling and Medical Information
Services combining Expert Knowledge with Data Science.
medpharmtec prepares, updates and reviews Product Information, so your specialists can focus on regulatory and medical assessment rather than repeated workloads.
We connect content, sources and review findings to give your team a traceable basis for its decisions and support a practical transition from document-centric to data-centric Product Information.
Labeling changes - Source and consistency reviews - Medical-response updates
Product Information experience since 1994.
Where repetitive work builds up
A source update has been assessed. Your team still needs to find the relevant passages, update related documents, compare versions and resolve questions before review can move forward.
When this work repeats across a portfolio, it becomes a capacity problem, not just a document task.
Focus expert review
Bring the relevant sources, findings and open questions together. Give reviewers a clearer basis for assessing the issues that require regulatory or medical judgment.
Make recurring delivery more predictable
Define repeatable inputs, checks and handovers. The objective is to manage a growing workload more systematically, rather than repeat the same preparation for every additional product.
Where can we support you
Complete a regulatory labeling or medical-information assignment
A change needs implementing, a document set needs checking or a response needs updating. Start with one work package.
Labeling change implementation
We implement specified changes in selected SmPCs, patient leaflets and related documents, then check them against the agreed references.
You receive: edited documents, a baseline comparison and questions requiring regulatory clarification.
Source and consistency review
We examine selected content against its sources, meaning and intended use. Different wording is not automatically an inconsistency.
You receive: findings with exact locations, supporting references and questions requiring assessment or correction.
Medical-response preparation and review
We prepare or update response documents for a defined inquiry and check them against the agreed product information and scientific sources.
You receive: a response document, supporting references and open questions for medical review.
Manage a recurring labeling workload
Growing volume is difficult to absorb when each assignment requires new source searches, unclear handovers and repeated clarification.
We examine a recurring workflow and define the preparation, checking and delivery steps that can be assigned to medpharmtec. Responsibilities and the expected handover are explicit.
Start with: one workflow across a selected product group, with an agreed delivery scope and measures of customer effort, turnaround and total cost.
Prepare existing content for data-centric labeling
Useful information remains scattered across files and review comments. Your team wants to reuse earlier work but cannot readily establish where it still applies.
We identify the content elements, source relationships and context needed for a specific task. The aim is useful structure, not a portfolio-wide transformation before work can begin.
Start with: one document set and a recurring task. Receive a content assessment and prioritized implementation steps; a structured sample can be included in the scope.
Discuss your requirementsSee what a review finding can contain
Illustrative example, not a customer case or measured outcome.
A reference statement contains a qualification that is absent from the corresponding draft passage.
Observation: The qualification is not represented in the selected passage.
Review question: Does the draft preserve the intended scope, taking its purpose and surrounding context into account?
Supporting information: The reference and draft passages, their exact locations, document versions and relevant context.
Status: Open for expert assessment. No correction assumed.
The result connects a text difference with its evidence and the question to resolve. Your team can assess the finding instead of first reconstructing its basis.
From document-centric to data-centric
A document shows the wording. The work also depends on its source, meaning, applicability and relationships to other content.
Data-centric labeling makes these relationships explicit. Identifiable statements can be connected to sources, product and market context, versions and review findings. Documents remain essential deliverables; the information behind them becomes available for more systematic analysis and reuse.
Expert Knowledge and Data Science
We start with what your reviewer needs to establish.
Regulatory and medical expertise guides the selection of relevant sources, context, and review criteria. Data science methods, such as text analysis, structured content models, and computational comparisons, are then applied to evaluate the content against these standards.
Expert review determines the significance of the findings. Earlier information is reused only after checking its currency and applicability; analytical output does not replace professional judgment.
Our four service areas
Framing
Prepare and structure content in relation to its sources, scope and intended use.
We connect statements to their source basis and practical context so content can be prepared for reliable downstream use.
Proofing
Examine factual support, consistency and meaning; document findings for assessment.
Review outputs combine text evidence, exact locations and questions that require expert judgment rather than automated assumptions.
Nudging
Organize and deliver information for a defined audience and decision.
We preserve evidence, context and required qualifications so information remains usable for regulatory and medical decisions.
Processing
Structure preparation, review and delivery with explicit responsibilities.
Defined versions, checks and handovers make recurring work more predictable across teams and product portfolios.
Working with medpharmtec
Define the assignment
We clarify the task, sources and result you need. Scope, deliverables, review responsibilities, timing and fees are agreed before work begins.
Complete the work
We perform the specified preparation, editing and analytical steps. Missing information, conflicting instructions and questions requiring your input are raised for clarification.
Review the handover
You receive the agreed documents and findings, with completed work and unresolved issues clearly distinguished. Your designated experts retain final regulatory and medical approval.
For recurring work, we agree how to assess value against a defined starting point. Total cost includes our fees and your remaining preparation, coordination, review and rework. Scope and quality criteria must remain comparable: reduced effort should not mean omitted work.
Company
About medpharmtec
medpharmtec specializes in product-information work across Regulatory Affairs, Labeling and Medical Information.
We combine domain expertise with data science to complete today's assignments and improve the information basis for subsequent work. Smart Product Information brings these together: the content, the knowledge required to interpret it and the processes needed to keep it usable.
Contact
Discuss your requirements
Bring your current assignment or a recurring workload problem. We will clarify the work involved, the result you need and whether medpharmtec is a suitable delivery partner.
You do not need a fully specified project to get in touch. A brief description, approximate volume and any target date are enough to start.
Frequently asked questions
Can we start with a single assignment?
Yes. A labeling change, document review or medical-response update can be a standalone project. Broader workflow improvements are considered separately.
Do we need a new system or changes to approved wording?
Not by default. A first project can use existing documents. Structuring information is separate from changing approved content; edits follow the relevant sources and agreed instructions.
How is the scope of a review defined?
We specify the sources, documents, criteria and activities included. Editing, source verification, literature research and regulatory or medical assessment are distinct activities, not interchangeable promises.
How do we share confidential information?
Before you send confidential materials, we agree the transfer method, access arrangements, processing scope and applicable data-handling requirements.