Comprehensive Drug and Biologic Development, Consulting, Contract Auditing, GCP Compliance, GLP Compliance, GMP Compliance, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation, Training
MORIAH Consultants provides regulatory affairs and clinical research consulting to the pharmaceutical, biotech and medical device industries. The firm provides a full range of regulatory and clinical services including; regulatory strategic planning, preclinical pharmacology/toxicology assessment, clinical study design, compliance audits, review/preparation of regulatory applications, representation and/or liaison with regulatory agencies and scientific groups, and expert witness services. The firm has dealt with Regulatory Authorities in numerous countries and supervised all aspects of product development and approval.
- Review, assessment, and critical evaluation of Investigational New Drug (IND) Applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA) and device applications (510k and PMA).
- Representation, contact, or liaison with regulatory agencies and scientific groups. (e.g., FDA, CHMP, EMA, NIH)
-Conduct site monitoring, site and investigator GCP audits, design and implementation of GCP compliance programs, including Part 11 compliance.
-Conduct facility assessment and GMP audits, implementation of GMP compliance programs (CAPA)
- Conduct training and educational seminars and courses on Regulatory Affairs, GMP/GLP/GCP Quality Assurance, and Clinical Audits
- Evaluation, review, assessment, and assistance at all levels in writing, editing, and coordination of product related reports and manuscripts.
- Expert witness testimony related to drug, biologic and device adverse reactions, product development issues and labeling claims
Dr. Hamrell has a unique background, with over 30 years experience in regulatory affairs, clinical research and drug development with academia, the FDA, NIH and in industry. He also worked for 8 years at the FDA and NIH in the development of drugs, biologics and vaccine products.