We provide professional services to our pharmaceutical customers so they will not have to spend the time, energy and resources to perform these tasks in-house. As a dynamic organization, Regcellent keep up-to-date on the latest information, data, laws and regulations of FDA, and maintain our own cutting-edge technology so you can rely on our services now and in the future. We assist pharmaceutical companies with Regulatory Services like, but not limited to:
- Establishment Registration
- Labeler Code and Drug Listing
- US Agent Services for both DMF and ANDAs
- SPL (Label) creation and uploading Services
- Full writing of eCTD ANDA ESG filings
- Conversion of CTD ANDA to eCTD ANDA ESG filings
- Converting DMF's to eCTD ESG filings
- Process Validation services (IQ, OQ, and PQ)
- cGMP Mock Audit Services and pre-approval inspections
- Conducting due diligence audits
- Quality Assurance Consulting Services & Training
- Providing consulting services related to FDA pharmaceutical policies and procedures
- Interpreting FDA policy and guidance documents related to cGMPs
- Reviewing laboratories for compliance with cGMP requirements
- Preparing SOPs for complaint handling, recalls, change control, employee practices failure investigations, etc.
- SOPs & Protocols Generation
- Providing recall advice and assistance as needed
- Reviewing Chemistry and Manufacturing Control (CMC) submissions to FDA concerning NDA, IND, ANDA and DMFs.
- FOI Services to obtain public documents to enable our clients to take informed decisions
