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.
