Customized Services
1. Registration dossier preparation tailored to  each target country’s requirements and to customer guidelines. 

2. REGISTRATION MAINTENANCE
  Management of processes necessary to inform regulatory authorities of any variations in product registration files. 

3. IN COUNTRY MANAGEMENT
  Provide and or manage local regulatory efforts in support yet independent from commercial distributors for filing and follow up.

4. PRODUCT REPRESENTATION
Hosting of product portfolio registrations through our network of local licensed legal entities, safeguarding your intellectual property.

5. REGULATORY PORTFOLIO MANAGEMENT
All encompassing management support to keep registration portfolio updated to the required degree of compliance as per the company’s and local government directives.

6. REGISTRATION DATABASE MANAGEMENT
Develop and maintain a detailed product registration portfolio database incorporating key parameters relevant to interested parties within the company and regulatory authorities. 

7. PACKAGING COMPONENTS MAINTENANCE
  Review and harmonize packaging components to the required degree of compliance as per the company’s and regional government directives. 

8. PHARMACOVIGILANCE SUPPORT
Assist in the coordination of pharmacovigilance requirements as needed. 

9. OTHER SERVICES
  In support of our core services we can also provide ancillary services such as:

• Document Translations
• Technical literature creation
• Registration Procedure Manuals

RETURN TO TOP

REGISTRATION SERVICES INCLUDE:

• Medical Products

• Veterinary Products

• Medical Devices

• “OTC” Products


And Other Prescription Products