Welcome to Adia (Shanghai) Pharma Co., Ltd.
E-mail us for further details
adia@adiapharma.com
 
OUR REGULATORY SERVICE....................................................



GMP Regulatory 

- China GMP
- International GMP (US FDA, EU GMP, TGA, PMDA, WHO etc.)
- NMPA Overseas Inspection




Regulatory Affairs 

- Imported Drug Registration
- Imported APIs Filing
- Quality Consistency Evaluation for Generic Drugs
- BE Studies
- US DMF Submission
- US FDA Establishment Registration, Self-Identification, NDC Application
- EU CEP/COS Application
- EU EDMF Submission




Third-Party Audit 

- Supplier/Vendor Assessment Audit
- Mock Audit
- Official Inspection Support (US, EU, WHO)           

 

Besides our own professional regulatory team, Adia Pharma has been working with reputed foreign consulting firms who have
extensive experiences to provide our partners with regulatory and cGMP consulting services in line with current requirements
from regulatory authorities in different territories.


 





OUR VALUE-ADDED SERVICE..................................................................................................................

 
To our customers
 
 
- Advancing your product development and saving time in the ANDA approval process. 
 
- Ensuring the manufacturing facilities we represent maintain a high level of compliance with cGMP. 
 
- Collaborating with manufacturers in establishing appropriate protocols & methodologies to prepare Drug Master File (DMF). 
 
- Sourcing APIs from China, India, EU to provide our customers with the products of best competitive value.







 
To our suppliers
 
- Exploring more new global business potential in different territories for your products.
 
- Assisting international API manufacturing partners to meet cGMP requirements in target markets and successfully complete 
   DMFs and FDA/EDQM inspections.
 
- Reviewing market potential as well as patent status of products.
 
 
 
                                                                      
 
 

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