Regulatory & Compliance
Health Authority Interaction.
We prepare pharmaceutical, biotech, and medtech companies for interactions with the EMA, FDA, BfArM, and other regulatory authorities—from scientific advice to communication during inspections.
Why do regulatory approvals often fail due to communication issues with the authorities?
Interactions with regulatory authorities are critical milestones in the approval process. An unclear strategy can jeopardize years of development:
- Unstructured questions lead to evasive or unusable responses from government agencies.
- Failure to prepare for critical questions during the meeting significantly delays the approval process.
- When communication during inspections focuses on findings, it becomes defensive rather than proactive and solution-oriented.
- Important regulatory deadlines are missed due to poorly coordinated communication among government agencies.
Have you established a formal process for systematically preparing for EMA Scientific Advice or FDA pre-submission meetings?
Our services in government communications.
We bring to the table our collective experience from hundreds of interactions with regulatory authorities on behalf of the pharmaceutical, biotech, and medtech industries.
Scientific Advice & Pre-Submission
Preparation of detailed question documents for Scientific Advice (EMA) and Pre-Submission Meetings (FDA). We strategically formulate questions to elicit definitive, actionable answers regarding clinical and CMC strategy.
Inspection Communication & CAPA
Drafting structured responses to regulatory findings following inspections. We develop CAPA plans that fully address the requirements and manage the communication process until closure.
National Authorities & Notified Bodies
Coordination of applications, variations, and inquiries submitted to national regulatory authorities (such as BfArM, MHRA, and Swissmedic), as well as managing interactions with Notified Bodies for medical device approvals.
Training & Communication Skills Training
Targeted training for your legal team and management on dealing directly with government agencies. Focus: clear communication, avoiding information overload, and confidently handling critical inquiries.
Frequently Asked Questions About Communication with Government Agencies.
What is the EMA's scientific advice procedure?
It is a formal consultation process in which companies clarify specific development issues with the EMA prior to submission. The responses are not legally binding, but they carry significant weight in subsequent marketing authorization decisions.
When should you request an FDA pre-submission meeting?
Ideally, very early on: before the start of regulatory clinical trials (e.g., pre-IND meeting) or before the final NDA/BLA/510(k) submission. This drastically reduces the risk of costly development errors.
What is the proper way to respond to critical findings following an inspection?
Structured, factual, and delivered strictly on time. The finding must be acknowledged, a root cause analysis must be provided, and the corrective actions (CAPA) must be transparent and have binding deadlines. Defensive responses provoke escalations.
How long does it take to prepare for a scientific advice meeting?
The process of drafting and finalizing the formal briefing document typically takes 4 to 8 weeks. The subsequent review process at the EMA generally takes 70 days after submission.
Additional expertise in regulatory strategy.
Expertise
International market access
Market access strategies for international markets and their regulatory authorities.
ExpertiseInspection Readiness
Prepare teams effectively for the on-site inspection.
ExpertiseRegulatory Affairs
Strategic market access throughout the entire product lifecycle.
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