4C Pharma
4C Pharma Solutions is a comprehensive healthcare solutions company dedicated to providing critical services such as Pharmacovigilance, Materiovigilance, Medical Information Call Center, Safety Database Hosting, Regulatory Affairs, and Medical Writing. Founded in 2014 by experienced medical doctors, the company aims to ensure safety, compliance, and efficiency in healthcare operations through innovative, turnkey solutions and a dedicated 2-in-the-box model. With a history of recognized excellence, including FDA inspections with zero findings and multiple industry awards, 4C Pharma Solutions is committed to delivering superior value and fostering strategic partnerships.
Industries
Nr. of Employees
small (1-50)
4C Pharma
15 Corporate Place South, Suite 110, Piscataway, New Jersey, USA. 08854
Products
Medical information contact center software platform
A cloud-deployed software platform to support medical information contact center workflows, case intake, and safety database connectivity; developed in collaboration with affiliated technology partners.
Medical information contact center software platform
A cloud-deployed software platform to support medical information contact center workflows, case intake, and safety database connectivity; developed in collaboration with affiliated technology partners.
Services
Managed pharmacovigilance operations including adverse event intake, case processing, signal management and regulatory reporting.
Medical device vigilance support including incident reporting and device safety surveillance.
Secure hosting and managed operations for adverse event and safety databases on cloud infrastructure.
Regulatory strategy, dossier preparation and market access support for submissions to regulatory authorities.
Authoring of clinical and regulatory documents including clinical study reports, safety narratives and regulatory documents.
24/7 medical information contact center services for product inquiries and safety case intake.
Managed pharmacovigilance operations including adverse event intake, case processing, signal management and regulatory reporting.
Medical device vigilance support including incident reporting and device safety surveillance.
Secure hosting and managed operations for adverse event and safety databases on cloud infrastructure.
Regulatory strategy, dossier preparation and market access support for submissions to regulatory authorities.
Authoring of clinical and regulatory documents including clinical study reports, safety narratives and regulatory documents.
24/7 medical information contact center services for product inquiries and safety case intake.
Expertise Areas
- Pharmacovigilance and drug safety operations
- Materiovigilance (medical device vigilance)
- Safety database hosting and administration
- Medical information call center operations
Key Technologies
- Cloud-based hosting and deployment
- Safety database / adverse event reporting systems
- Medical information contact center platforms
- Automated workflow and case management systems
News & Updates
Top 10 CROs by PharmaIQ
Recognized as one of the top CROs in 2016.
FDA Inspection Success
Successfully navigated the first FDA inspection with zero findings in 2017.
Innovative MICC Software Development
Co-developed TrominoCARE, an advanced MICC software, in 2018.
Venturing into Rare Product Market
Onboarded three pharmaceutical companies in the Rare Product Segment in 2019.
Top 100 Most Innovative Service Providers
Honored in 2020 for uninterrupted service during the pandemic.
Best Startup 2022
Received accreditation as one of the '15 Best New Jersey Call Center Companies and Startups'.
Top 10 CROs by PharmaIQ
Recognized as one of the top CROs in 2016.
FDA Inspection Success
Successfully navigated the first FDA inspection with zero findings in 2017.
Innovative MICC Software Development
Co-developed TrominoCARE, an advanced MICC software, in 2018.
Venturing into Rare Product Market
Onboarded three pharmaceutical companies in the Rare Product Segment in 2019.
Top 100 Most Innovative Service Providers
Honored in 2020 for uninterrupted service during the pandemic.
Best Startup 2022
Received accreditation as one of the '15 Best New Jersey Call Center Companies and Startups'.