Drug Information Association Logo
Advertisement

MORIAH Consultants

Description: 

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.  

Regulatory Affairs

- 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)

QA Compliance

-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

Medical/Technical Assessment

- 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.  

Services: 

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

Contact Information: 

MORIAH Consultants
4481 Paloma Lane
Yorba Linda, CA, 92886-2832, USA
Phone : 7149700790
Fax : 7149700934
Internet : http://www.moriahconsultants.com
Email : michael@moriahconsultants.com
Contact Person : Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, President