Hanna B.

Biotech & Pharmaceutical Regulatory, GMP, and Scientific Writing Expert I help biotechnology and pharmaceutical companies with regulatory documentation, GMP compliance, SOP development, process validation, and scientific writing and review. I hold a Ph.D. in Biochemistry and bring over 40 years of experience in the biotechnology and pharmaceutical industries, combining scientific expertise with hands-on regulatory, quality, and manufacturing experience. My areas of expertise include: Regulatory Affairs & CMC: Preparation and review of regulatory submissions, technical documentation, and CMC sections for FDA, EMA, and other regulatory authorities. GMP & Quality Assurance: SOP writing and review, deviations, CAPA, change control, quality documentation, and compliance assessments. Process Development & Validation: Biotechnology manufacturing processes, equipment qualification (IQ/OQ/PQ), process validation, and analytical documentation. Scientific & Technical Writing: Scientific literature reviews, technical editing, research reports, product documentation, and critical evaluation of scientific claims. Biotechnology Project Evaluation: Scientific feasibility assessments, technology evaluations, and review of innovative biotechnology projects. Professional background: I have held senior positions at Biotechnology General (Ferring), Omrix Biopharmaceuticals (Johnson & Johnson), and InterPharm Laboratories (Merck), with additional process validation experience at Kamada. I also evaluate innovative biotechnology projects for the Israel Innovation Authority and have published scientific research in peer-reviewed journals, including PNAS, Biochemistry, Nucleic Acids Research, and the Journal of Biological Chemistry. What you can expect: Accurate scientific and technical work, clear documentation, practical regulatory insight, and deliverables tailored to your project's requirements. I am available for focused consulting assignments, document preparation and review, and short-term biotechnology projects.