PV Solutions-Promoting safety,Delivering Excellence.

Pharmacovigilance and Drug Safety Services

Pharmacovigilance and all drug safety issues are relevant to everyone in this world whose life is touched in any way by medical interventions. PV Solutions team comprises of expert professionals who develop and implement customised strategies for PV and Drug safety services for companies worldwide.
The Government of India recently announced that the Pharma Companies must ensure that a compliant PV system is implemented within their Companies. The Government is now expecting the Pharma Companies to follow PV guidelines, and has already mandated Market Authorisation Holders (MAHs) to set up PV cells in their companies in accordance with the Drugs and Cosmetics Rules. It is now the responsibility of PV cell of the companies to collect, process and forward the report to the licensing authority for information on Adverse Drug Reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MAH in the country.
We can step in here and fully support you in establishing a fully compliant PV system and PV quality management system with the help from our team who have rich experience in setting up the systems in the European countries. Our team also provide training and consultancy support to PV centres located in India and across the globe. Moreover, we have experience in writing various PV related documentation such as Aggregate reports, RMPs, PSMFs and critical SOPs to support MAAs in the EU. Our team also reviews the documents intended for EU submissions.
As a company we believe in the power of collaboration, and through integrated partnerships with our collaborators, we offer clients the best possible solutions for their needs. All of our employees understand our client’s unique needs and mould their approach and processes accordingly. We maintain the quality and support in improving your probability of success. We know that the focus must always be directed towards establishing a unique drug safety ecosystem in India and across the globe.

Pharmacovigilance Medical Writing

PV Solutions medical writing team is well-experienced in writing different types of PV documents and can provide a comprehensive solution to a client for aggregate reporting. Our medical writers also undergo continuous training and have the ability to prepare documents in accordance with relevant guidelines. We can support you with the writing of various documents such as:

Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMSs);
Pharmacovigilance System Master Files (PSMFs);
Periodic Benefit-Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs);
Addendum to Clinical Overviews (ACOs);
Periodic Adverse Drug Experience Reports (PADERs);
Developmental Safety Update Reports (DSURs);
Standard Operating Procedures (SOPs);
Literature search, analyses and ad-hoc benefit-risk assessments.

Pharmacovigilance Quality Management System

We offer our services to support small to medium sized pharmaceutical companies toestablish PV quality management systems based on standard guidelines for pharmacovigilance in India. It is inspired by the good pharmacovigilance practices devised by EMA, and will truly serve the purpose of ensuring the safety of patients. We can advise you on establishing a PV system in India and can also help you to transfer the system in-house in case it has been established previously on an outsourcing model.

Pharmacovigilance Regulatory Inspection

Various Regulatory Authorities are coming together and exchanging information regarding the findings from the PV inspections they conduct at different pharmaceutical companies. The PV systems are being scrutinised and assessed in great depth during inspections. We can support you by identifying any gaps in your PV system prior to inspection and help you in rectifying those gaps in the best possible way. We can help and guide you so that you are well-prepared for the inspection, with our following services:

Inspection Readiness: We provide a complete package including guidance, training and support leading up until the actual inspection, and also during the inspection.
Mock Inspection: We conduct mock inspections to mimic the real inspections. This will help you to understand the inspection process better and prepare you to face the questions from the inspectors in a real inspection situation.
Summary of Pharmacovigilance System (SPS): We provide support to complete the SPS which requires submission to Regulatory Authorities prior to the inspection.
Corrective and Preventive Action (CAPA) Plan: We can also provide post-inspection support for putting together the CAPA plan and then managing it up until its completion.

Auditing Services

Due to the stringent regulations and increasing demands from Regulatory Authorities, the pharmaceutical companies must ensure that a robust PV system is in place which is being monitored and improved continuously in order to provide patient safety. We can help you to achieve this to high standards with our following services:

Conducting Audits: Our audit activity includes conducting audits of pre and post marketing PV systems and documentation, affiliates, distributors, marketing partners and service providers, QPPV Office, process audits such as patient support programmes and aggregate report writing processes, etc.
Conducting Gap Analysis: We conduct gap analyses and identify gaps in PV systems by assessing against the regulatory requirements. We offer expert advice and solutions to rectify any deficiencies observed during these analyses.
Preparing Checklists for Audits: We provide checklists to support and guide the auditors during the audit process. This is also included in our training programme for conducting PV audits.
CAPA Management: We provide post-audit and post-inspection support for CAPA management. We provide expert advice on performing root cause analyses and determining a suitable CAPA plan to address the findings. This is then followed up with the implementation of the CAPAs within the timelines agreed with the Regulatory Authorities.