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.
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
4481 Paloma Lane
Phone : 7149700790
Fax : 7149700934
Internet : http://www.moriahconsultants.com
Email : email@example.com
Contact Person : Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, President