FOR PATIENT SAFETY

GSS Pharma provides an end-to-end Pharmacovigilance services to Pharmaceutical companies globally.

We help the global pharmaceutical and healthcare industry, address the dynamics of Drug safety and Pharmacovigilance, by impeccably integrating its deep-rooted knowledge expertise and strategizing customized business outcomes for synergistic growth.

We believe in process excellence with an unwavering quality commitment which is achieved by our expertise staff who are highly qualified and skilled experts who strive hard to deliver complaint pharmacovigilance services to the companies with an uncompromised quality objective.

Our approach is to partner and grow along ensuring trusted and ideal relation for all the business needs with technically competent professionals with practical domain experience in services that we offer.

We undertake the entire pharmacovigilance responsibilities of our clients starting from but not restricted to

• EMA account management.
• SPOR registration.
• QPPV assistance to clients along with access assistance to Eudravigilance portal including EV-WEB and EV-DAS.

An expertise team with overall knowledge on pharmacovigilance process with understanding on pre-grant and post grant activities. We take care of

• Submission of Risk management plan as part of initial dossier submission.
• Global literature monitoring of molecules by using EMBASE and Medical literature monitoring from EMA.
• Update of SmPC in XEVMPD after the receipt of grant from Health Authority.
• Downloads of ICSR from Eudravigilance.
• Handling of spontaneous cases along with its submission to Health Authority.
• Updates to Risk management plan.
• A diligent follow-up with PRAC recommendations for safety concerns.
• EURD list check and preparation and submission of PSUR/PEBRER.
• Annual SmPC review for clients.
• Addendum of clinical overview (ADCO) along with clinical expert statement for product renewals.

We at GSS Pharma offer

Process excellence + Efficient and expertise staff + Best price in service Industry

Our pharmacovigilance services Include

• QPPV services.
• Pharmacovigilance System Management including EU Pharmacovigilance System Master File, Summary of Pharmacovigilance System and Procedural documents.
• Risk Management includes Risk Management Plan, Risk Evaluation and Mitigation Strategies, Annual Safety Reviews.
• Signal Detection and Evaluation.
• ICSR Case Management: Triage and Data entry, Quality review, Medical review, Final review and submission to National competent authorities (NCA).
• Worldwide Scientific Literature Management: Screening and Processing of Literature Reports
• PSUR/PBRER/Aggregate Reports: Preparation, Evaluation and Submission.
• Extended EudraVigilance Medical Product Dictionary-XEVMPD Maintenance.