CRMO will assist your company in the development of GMP Quality Systems including Standard Operating Procedures (SOPs), batch records, change control, revalidation, documents management, complaints management, annual product reviews, Quality Control specifications, test methods and validation protocols, etc.
Validation & Qualification
CRMO is one of the leading GMP consulting company involved in the preparation and execution of IQ, OQ, and PQ protocols and final reports for equipment, utility systems, laboratory instruments, processes, and computerized systems. CRMO offers services like preparation of Analytical method validation protocols and Analytical method validation reports including reviews of data, Cleaning Validation ,Product Validation , Stability studies, etc.
Regulatory Agency Documentation
CRMO can assist your company with FDA pre and post approval inspections, QA/QC documentation review, regulatory interpretation, and submissions such as Drug Master Files for submission to the United States FDA and the European Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, Responses to audit reports and follow up activities,-Site Master Files .CRMO can also help companies in Resolving Compliance Issues such as FDA Form FD-483 Response, Warning Letter Response, Application/Data Integrity Issues, Disqualification Letter Responses & Strategies, etc
QA & RA Set Up Support
The team of experts at CRMO assists the manufacturers to implement their GMP set ups. The service includes of all SOP’s, validation & qualification, protocols, BMR’s, training and records of training.