H. Baker
STREAMLINE YOUR MEDICAL AFFAIRS
ONE-STOP SHOP for medical content production
Outsource Medical Expertise for pharmaceutical companies, CROs, biotech and start-ups.
We provide certified physician-led medical expertise services, including medical writing, medical affairs and consulting to help organisations communicate complex medical information with clarity, compliance, and confidence.
Bridging the gap between clinical accuracy and business strategy.
Whether you need high-quality medical writing services for regulatory submissions and publications or strategic medical affairs support, we deliver every project with precision, speed, and reliability.
Our consultancy offers a flexible, scalable alternative to traditional agencies - ensuring direct collaboration, transparent pricing, and founder-level quality control.
Services include:
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Medical writing and regulatory documentation
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Medical affairs and MSL-on-demand consulting
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Clinical and scientific content development
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Medical translation
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Commercial and medical content review
We rigorously follow the key regulatory frameworks that shape medical content across Europe and global markets, including EFPIA, GDPR, FDA standards, ICH, GCP, GVP, ISO 14155, MDCG guidance, and MHRA requirements.
This ensures every claim is evidence-based, every statement is compliant, and every deliverable is ready for scientific scrutiny.
LEAVE COMPLIANCE QUESTIONS TO US
REDUCE YOUR REVIEW-CYCLE FRICTION
Less rewriting. Fewer red flags. Faster approval.
Our Process
Our consultancy process is straightforward. We start by understanding your medical writing and consultancy needs, then create a customized plan to address them.
Our certified physicians operate with a strict, regulation-first approach, ensuring every medical document meets the highest standards of accuracy, transparency, and compliance.
We use only fresh, high-quality references and aligning all content with EFPIA, ICH, GCP, GVP, GDPR, ISO 14155, MHRA and FDA principles from the start.
ENHANCE QUALITY, SPEED, AND CLARITY WITH OUTSOURCE MEDICAL
Here is what they say about our writers
SYMPTOMA.COM
They wrote texts on various medical topics for SYMPTOMA. All tasks were performed timely and thoroughly, an enthusiastic author with strong knowledge background in medicine!
Berlin-Chemie / Menarini
Successfully communicated with HCPs and KOLs, prepared scientific engagement materials, lead the training of medical representatives. A proactive and commercially oriented professional, able to understand the needs of marketing efforts.
Jekabpils Regional Hospital
Exceptional clinical judgement, reliability under pressure, and commitment to patient safety.
Get in Touch
Have a question or need more information? Reach out to us today. Our team is ready to assist you with your medical writing and consultancy needs.