Regulatory / cGMP Compliance
We offer customer and FDA audit hosting assistance. Our regulatory compliance service is centered mainly on helping our customers host quality audits that showcases the strengths of their quality management systems and documentation program. We understand that in bidding for new product and technical services, the audit process is a necessary hurdle that must be successfully managed. Our firm will coach and guide your internal staff before and during a customer audit to win the potential business. We partner with your Quality and Sales staff early in the bidding process to ensure that the necessary systems are in place to support the eventual customer or government audit.
Product details
Over-the-counter drug and cosmetic firm FDA registration - We help your firm register your OTC or cosmetic business with the FDA to manufacture and distribute your products.
US Agent Services
DEA licensing assistance - We coach and assist your to obtain list 1 chemical licensing.
Product Registration - We can file your annual product registration, annual reports as well as adverse drug event reporting.
Internal Quality Systems Audit
Vendor and Contract firm Quality Audit
Process Qualification
Equipment Qualification
Utility System Qualification
Product price or special offer
We offer various product packages ranging from full service comprehensive regulatory services to A-la-carte services.
| | Service 1 | Service 2 |
| Drug Firm Registration | | |
| Cosmetic Firm Registration | | |
US Agent Services (1-2 Lots/month) | | |
| | Service 1 | Service 2 |
US Agent Services (3 - 5 Lots/month) | | |
US Agent Services (6 -10 Lots/month) | | |
| | Service 1 | Service 2 |
| DEA Licensing Services | | |
| Drug Product Registration | | |
Drug Product Registration (Additional lots after first) | | |
Cosmetic Product Registration | | |
Cosmetic Product Registration (Additional Lots after first) | | |
| Quality Systems Audit | | |
| Documentation Systems Audit | | |
| Facility/Utility Systems Audit | | |
| | Service 1 | Service 2 |
| Vendor Audit | | |
| Validation Systems Audit | | |
| Vendor Qualification | | |
| | Service 1 | Service 2 |
| Manufacturing Process Qualification/Validation | | |
| Equipment Qualification/Validation | | |
| Utility System Qualification/Validation | | |
We Accept the following payment forms