Best Pharmacovigilance Services Provider in India
End-to-End Drug Safety and Compliance Solutions
We at ACPL provide exhaustive Pharmacovigilance (PV) services aimed at assisting pharmaceutical, biotechnology, and medical device organizations with worldwide safety and regulatory demands. With 25+ years of rich experience and a team of specialized professionals, we guarantee complete lifecycle management of your drug safety processes ranging from clinical trials to post-marketing surveillance.
Our services are aligned with international regulations such as ICH, GVP, CDSCO, EMA, MHRA, US FDA, and other global health regulators. Whether you wish to outsource your full PV operations or simply require certain services, ACPL provides tailored, effective, and inspection-ready assistance.
Our Pharmacovigilance Service Offerings
Pharmacovigilance System Master File (PSMF)
- Preparation, writing, and regular updation of PSMF
- Day-to-day updations to keep in compliance with EU/EEA regulations
- 24/7 inspection-readiness for National Competent Authorities
QPPV & LSO Services
- EU-QPPV and EU-LSO services for India, EU, CIS, MENA & LATAM
- deployment and coordination
- regulatory intelligence, literature monitoring, and case processing
ICSR Case Processing
- End-to-end handling of Individual Case Safety Reports
- Case triage, MedDRA coding, narrative writing, medical review, and submission
- 100% QC with exceeding industry compliance standards
Literature Monitoring
- Global and local literature screening (weekly/ongoing)
- dentification and triage of literature-based ICSRs
- Smooth integration with ICSR workflow
Aggregate Safety Reports
- Writing of PSURs, PBRERs, DSURs, PADERs, ASRs, and Addendums
- Calendar planning, tracking, and compliance management
- Submission-ready reports in all formats as required
⚠️ Signal Detection & Risk Analysis
- dentification, contextualization, evaluation, and closure of signals
- Medical review, literature search, and epidemiological analysis
- Signal assessment reports drafted in accordance with GVP standards
Risk Management Plans (RMPs)
- Preparation of RMPs and development of Risk Minimization Measures (RMMs)
- Development of websites, educational content, medication guides
- Survey and data analysis-driven RMM effectiveness analysis
Safety Data Exchange Agreements (SDEAs)
- Preparation and review of SDEA by country
- Setup of process and reconciliation with SDEA partners
- Compliance and performance monitoring on an ongoing basis
Quality & Compliance
- Setup of Pharmacovigilance Quality Management Systems (QMS)
- SOPs, CAPA setup, audit support, and inspection readiness
- gap analysis, GVP audits, continuous quality improvement
Expert Medical & Safety Writing
- Narrative preparation, RFI response, DHCP letters
- Integrated Safety Summaries (ISS), Clinical Overviews, Benefit-Risk Reports
- High-quality writing as per global regulatory requirements
________________________________________
Why ACPL?
- 25+ Years of Regulatory & Compliance Experience
- Global Pharmacovigilance Solutions with Local Touch
- Inspection-Ready Systems & Docs
- Expert QPPVs, Physicians, Scientists & PV Professionals Team
- Fully Scalable Solutions for Startups to MNCs
________________________________________
Ready to Reinforce Your Drug Safety System?
Reach out to us today and discover how we can assist your global pharmacovigilance operations with reliability, compliance, and unparalleled expertise.
Contact Us
ACPL – Leading Pharmacovigilance Services Provider in India
Address:
B-3, Sector-6, Noida – 201301
Uttar Pradesh, India
Phone: +91-9266665201,+91-9310040434
Email: info@acpl.com
Office Timings:
Monday – Saturday: 10:00 AM – 6:00 PM
Sunday: Closed
