Pharmacovigilance Consulting Services in India
Professional pharmacovigilance and drug-safety consulting support for pharmaceutical companies, Marketing Authorisation Holders, manufacturers, importers and healthcare organisations.
Accredited Consultants Private Limited (ACPL) provides pharmacovigilance consulting and regulatory support to pharmaceutical companies, Marketing Authorisation Holders, manufacturers, importers and organisations managing medicine-safety requirements in India.
What Is Pharmacovigilance?
Pharmacovigilance (PV) is the science and activities concerned with detecting, assessing, understanding and preventing adverse effects or other medicine-related safety problems.
For pharmaceutical companies, an effective pharmacovigilance system helps maintain ongoing assessment of the safety profile and benefit-risk balance of a medicinal product throughout its lifecycle.
Why Is Pharmacovigilance Important in India?
Pharmaceutical companies need appropriate systems to identify, document and manage safety information after a product enters the market.
- Monitor adverse drug reactions (ADRs)
- Collect and process safety information
- Identify potential safety signals
- Evaluate emerging safety risks
- Maintain Individual Case Safety Reports (ICSRs)
- Support PSUR preparation
- Maintain Pharmacovigilance System Master File (PSMF)
- Support Risk Management Plans where applicable
- Respond to applicable regulatory requirements
- Maintain ongoing product safety surveillance
Pharmacovigilance Consulting Services in India
PV System Setup
Support for developing appropriate pharmacovigilance processes, responsibilities, workflows, SOPs and documentation systems.
ICSR Support
Support related to case intake, assessment, processing, follow-up and applicable safety-reporting activities.
PSMF Consulting
Support for preparation, review and maintenance of the Pharmacovigilance System Master File.
PSUR Support
Assistance with applicable Periodic Safety Update Report planning, preparation and regulatory submission support.
PV SOP Development
Development and review of SOPs covering applicable pharmacovigilance processes.
Signal Management
Support for safety-data review, potential signal identification, assessment and follow-up activities.
Risk Management Plan
Support for applicable risk identification, pharmacovigilance activities and risk-minimisation documentation.
PV Audit Support
Pharmacovigilance system audits, gap assessments, documentation review, CAPA and inspection-readiness support.
PV Training
Training support covering ADRs, ICSRs, PSUR, PSMF, signal management, SOPs and PV quality systems.
Post-Marketing Surveillance
Support for safety-data monitoring, ADR collection, literature monitoring and applicable periodic reporting.
Pharmacovigilance System Master File (PSMF)
A Pharmacovigilance System Master File (PSMF) provides documented information about an organisation's pharmacovigilance system.
ACPL can support applicable organisations with:
- PSMF preparation
- PSMF review
- PV system documentation
- Organisation and responsibility structure
- Safety-data sources
- Safety-reporting processes
- Quality-management information
- PV system maintenance
Periodic Safety Update Report (PSUR) Support
A Periodic Safety Update Report (PSUR) provides periodic evaluation of accumulated safety information and the benefit-risk profile of a medicinal product where applicable.
ACPL can assist with:
- PSUR planning
- Safety-data collection coordination
- Safety-information review
- Benefit-risk evaluation support
- PSUR preparation
- Regulatory submission support
Individual Case Safety Report (ICSR) Support
Individual Case Safety Reports are an important component of pharmacovigilance activities.
ACPL can provide support related to:
- Case intake
- Case processing
- Case assessment
- Safety-information documentation
- Follow-up information
- Applicable reporting processes
Pharmacovigilance SOP Development
Standard Operating Procedures help establish consistent, documented and traceable pharmacovigilance processes.
- ADR intake
- ICSR processing
- Case follow-up
- Literature monitoring
- Signal management
- PSUR preparation
- PSMF management
- Safety reporting
- PV audits
- Training and competency
Pharmacovigilance Audit & Inspection Readiness
A pharmacovigilance system should be capable of demonstrating that defined procedures are implemented effectively and that appropriate documentation is maintained.
ACPL can support organisations with:
- PV system audits
- Compliance gap assessments
- SOP compliance reviews
- Documentation reviews
- CAPA support
- Inspection-readiness activities
- Quality-system assessments
Pharmacovigilance Programme of India (PvPI)
The Pharmacovigilance Programme of India (PvPI) is the Government of India's flagship drug-safety monitoring programme.
The Indian Pharmacopoeia Commission functions as the National Coordination Centre (NCC) for PvPI. The programme collects, collates and analyses drug-related adverse events as part of India's drug-safety monitoring framework.
Who Needs Pharmacovigilance Consulting Services?
Pharmaceutical Companies
- Pharmaceutical manufacturers
- Marketing Authorisation Holders
- Drug importers
- Generic pharmaceutical companies
Healthcare & Biotech
- Biotechnology companies
- Biological-product companies
- Vaccine manufacturers
- Healthcare organisations
International Companies
- Global pharmaceutical companies
- Foreign manufacturers
- International MAHs
- Companies entering India
Pharmacovigilance Compliance Process in India
Regulatory Assessment
Understand the product, marketing status and applicable pharmacovigilance obligations.
PV System Gap Assessment
Review the organisation's existing pharmacovigilance system and identify potential gaps.
SOP & Process Development
Establish documented procedures for applicable pharmacovigilance activities.
Safety Data Collection
Establish appropriate channels for receiving safety information.
ICSR Processing
Evaluate and process applicable individual safety cases.
Signal Management
Identify and evaluate potential safety signals.
Periodic Reporting
Prepare applicable PSURs and other safety reports.
Regulatory Submission
Submit applicable reports and responses through prescribed regulatory channels.
Continuous Monitoring
Continue monitoring the product's safety profile and benefit-risk balance.
Why Choose ACPL for Pharmacovigilance Consulting in India?
Accredited Consultants Private Limited (ACPL) provides regulatory consulting support to pharmaceutical and healthcare companies navigating India's regulatory environment.
Regulatory Assessment
Assessment of applicable product and pharmacovigilance requirements.
PV System Development
Support for appropriate pharmacovigilance processes and documentation.
Documentation Support
Assistance with applicable SOPs, PSMF, PSUR and RMP documentation.
Compliance Support
Identification of potential compliance gaps and process improvement support.
Regulatory Support
Assistance with applicable regulatory submissions and communications.
Ongoing Support
Continuing pharmacovigilance and regulatory support based on organisational requirements.
Pharmacovigilance Consultant in Noida, Delhi NCR & Across India
ACPL is located in Noida, Uttar Pradesh, and provides pharmacovigilance and regulatory consulting services to companies across Delhi NCR and India.
Our services can support organisations in Delhi, Noida, Greater Noida, Gurugram, Ghaziabad, Mumbai, Bengaluru, Hyderabad, Chennai, Ahmedabad, Pune and other locations across India.
Address:
B-3, Sector-6, Noida – 201301,
Uttar Pradesh, India
Phone:
+91-9266665201
+91-9310040434
Email:
info@acplgroupindia.co.in
Frequently Asked Questions
What are pharmacovigilance consulting services?
Pharmacovigilance consulting services help pharmaceutical companies establish, maintain and improve systems for monitoring medicine safety and managing applicable regulatory pharmacovigilance responsibilities.
Is pharmacovigilance required in India?
Applicable pharmaceutical manufacturers, importers and Marketing Authorisation Holders may have pharmacovigilance obligations under India's regulatory framework. Specific requirements depend on the product and applicable regulatory pathway.
What is PvPI?
PvPI stands for Pharmacovigilance Programme of India, the Government of India's flagship drug-safety monitoring programme. The Indian Pharmacopoeia Commission functions as its National Coordination Centre.
What is a PSMF?
A Pharmacovigilance System Master File documents important information about an organisation's pharmacovigilance system, processes, responsibilities and quality-management arrangements.
What is PSUR?
A Periodic Safety Update Report is a periodic safety report used to evaluate accumulated safety information and the benefit-risk profile of a medicinal product, where applicable.
Does ACPL provide pharmacovigilance consulting across India?
Yes. Accredited Consultants Private Limited operates from Noida and provides regulatory and pharmacovigilance consulting support to businesses across India and international markets.
Looking for Pharmacovigilance Consulting Services in India?
Get a product-specific pharmacovigilance and regulatory assessment from ACPL.
Get a ConsultationConclusion
Pharmacovigilance is an important component of pharmaceutical product safety and regulatory compliance. Companies need appropriate systems for collecting safety information, evaluating risks and fulfilling applicable reporting responsibilities.
A professional Pharmacovigilance Consultant in India can help pharmaceutical companies establish appropriate PV processes, prepare documentation, support safety reporting and maintain applicable regulatory compliance.
Accredited Consultants Private Limited (ACPL) provides pharmacovigilance and regulatory consulting support from Noida to pharmaceutical and healthcare companies across India and international markets.