4C Drug Safety Services LLP Supplier Profile
   
Supplier Profile
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Public Profile:  http://discovery.ariba.com/profile/AN01522454466  |  ANID: AN01522454466  | Last Update: 13 Aug 2020
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4C Drug Safety Services LLP
Bangalore, Karnataka, India
Pharmacovigilance, Medical Information Call Center, Regulatory Affairs, Adverse Event, Case Process
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Description
4C was established by Medical Doctors who worked in the roles of Clinical Research Coordinator, CRA, Medical Reviewer and end-to end Pharmacovigilance services including MICC, Literature Search, Case Processing, Signal Detection, and Aggregate Reports.    
   
Having gained hands on expertise and learnt the best practices across different pharmaceutical manufacturers and pharmacovigilance service providers, we joined together and established 4C Pharma Solutions; 4C being defined by the 4 C’s: Complete, Correct, Consistent and Compliant with focus on Pharmacovigilance, Regulatory Affairs, Medical Writing, Quality Assurance and Training.  

We started by establishing 4C as a process driven company with strong emphasis on providing the best services to the Pharma industry maintaining Quality processes and Data Security. We are ISO 9001:2015 and ISO 27001:2013 certified. 4C is an Oracle partner with a fully implemented cloud hosted in-house ARGUS software, eXtedo eCTD Manager, MasterControl, TrominoCARE to cater to clients who want to spend quality time on drug safety and development leaving the technology operations and maintenance to us.     
Domain experts manage the day-to-day operations and provide real time consultative cost effective solutions applying the best practices at work to each client making your responsibility truly our passion.    
We have an excellent team with well-established facilities capable of providing 24/7 support in Regulatory Submissions, Medical Writing, Medical Information Call Center, Literature Search, Case Processing, Signal Detection, Aggregate Reporting, and training on Pharmacovigilance processes and software applications like Argus and ARISg.    
4C team also has expertise in working on multiple safety and regulatory applications like ARISg, CARES, SCEPTRE, ClinTrace, eXtedo, Register, Lorenz resulting in shortened time and effort for project to go live.     
Below is the full list of customizable services we provide to suit your needs:    

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
               
       Pharmacovigilance                                
               
               
       Regulatory Affairs                                
               
               
       Medical Writing                                
               
               
       Specialty Services                                
               
               
       Staffing Solutions                                
               
               Medical Information                                  
                   
               Regulatory Strategy & Consulting                                  
                   
               Clinical / Safety Writing                                  
                   
               Patient Support Programs (PSP)                                  
                   
               Clinical Research                                  
                   
               Literature Search                                  
                   
               Regulatory Writing                                  
                   
               Technical Writing                                  
                   
               Market Research Programs (MRPs)                                  
                   
               Pharmacovigilance & Risk Management                                  
                   
               Case Processing and Medical Review                                  
                   
               Regulatory Publishing & Submissions                                  
                   
               Scientific Writing                                  
                   
               Social Media Analytics (SMA)                                  
                   
               Biostatistics                                  
                   
               Report Submission                                  
                   
               Strategic Labeling Support                                  
                   
               Medical Writing for Devices                                  
                   
               SOP Writing                                  
                   
               Regulatory Affairs                                  
                   
               Periodic Reporting                                  
                   
               Lifecycle Management                                  
                   
               
       4C                                
               
               QMS Process establishment                                  
                   
               Clinical Data Management                                  
                   
               Signal Detection & RMP                                  
                   
               Regulatory Support for Medical Devices                                  
                   
               ISO 9001 & 27001 certification support                                  
                   
               Medical & Scientific Writing                                  
                   
               Argus, ARISg validation & Training                                  
                   
               
       Operational Excellence, Consultation, Support and Governance                                
               
               Quality Assurance                                  
                   
   
     
 
 
We would love to work collaboratively with you to help us both grow. If you are interested in knowing more, I would like to set up a meeting to discuss our services in detail and the benefits of working together.    
We would also like to tell you more on how you can evaluate our services as a pilot so that we can prove our quality and worth to your company before giving us a full-fledged project.    
We would like to be your partner and have you delegate some of these tasks to our capable hands. Please let me know when we can set a time to talk further.
Business Info
Legal & Fiscal
Certifications

Type of Org: Corporation

Business Type: Service Provider

Year Founded: 2014

  • ISO: ISO 9001 Certified (Quality Management), ISO 27001 Certified (Information Technology - Security Techniques)
Ship-to or Service Locations
Product and Service Categories
Industries
  • Global
  • Commercial pharmaceutical services
  • Healthcare
  • Pharmaceuticals
  • Service Provider
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