 |
Quality Assurance and Regulatory Affairs
PharmaForm has a dedicated Quality Assurance and Regulatory Affairs Department, which utilizes the vast experience of its team members to insure quality and customer satisfaction. Our QA team strives to maintain the best quality systems, thus providing you the highest assurance that your products meet all regulatory and quality requirements. Additionally, our Regulatory Affairs group can assist you with review and counsel of CMC issues as well as assist in CMC Documentation and Reporting.
PharmaForm's Quality Assurance and Regulatory Affairs groups are housed in the same facility as our Analytical and Manufacturing Services teams, thus our highly trained QA team are involved in all aspects of drug product development, clinical trial manufacturing and commercial manufacturing.
Our laboratory facility operates under Good Manufacturing Practices (cGMP) guidelines, and the stability testing facility is ICH compliant and conforms to DEA requirements for controlled substances. PharmaForm is registered with the FDA and registered and inspected by the Drug Enforcement Administration (DEA).
PharmaForm has been audited by our customers, consultants, the FDA and the DEA for regulatory compliance.
Our services include:
- Development of Regulatory Dossier
- Counseling, Documentation and Reporting of CMC
- Evaluate and Report Stability Data
- Statistical Evaluation according to ICH guidelines
- Assemble and Prepare Stability Sections for Submissions
- Client Consulting
- Client Representation at meetings with regulatory authorities
- Agency Response preparation
- Equipment and Process Qualification/Validation
<< back
|
