Aicha H.

Technical Advisor helping life sciences companies bring safe and innovative healthcare products to market.

With several years of experience in clinical research, regulatory compliance, and medical device innovation, I help pharma, biotech, and medtech teams turn complex challenges into clear, actionable strategies.

Thanks to my dual background in pharmacy and business, I naturally connect scientific rigor with operational and strategic thinking. I enjoy working hand-in-hand with teams to design practical solutions that improve quality, streamline processes, and accelerate market access all while staying compliant with demanding international regulations.

✅ Need to accelerate your clinical development while maintaining compliance?

✅ Facing hurdles in regulatory strategy or product lifecycle management?

✅ Looking to strengthen your quality systems or innovation pipeline?

Let’s turn your ideas into impactful, compliant solutions that deliver real results.

I’d love to discuss your next project and make it happen together.

🔧 Core Skills

🔹 Clinical trials & Regulatory compliance (IVDR, MDR, FDA)

🔹 Quality management systems (ISO 13485, 21 CFR Part 820, GxP)

🔹 Regulatory strategy & technical documentation

🔹 Product lifecycle management & market clearance

🔹 Risk management, CAPA, validation & audit readiness

🔹 Project leadership & cross-functional collaboration

🔹 Stakeholder communication & scientific writing

🎓 Background

Certified in Regulatory Affairs and Quality Systems

Six Sigma Green & Black Belt Certified