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Pharmacovigilance

The pharmacovigilance department of Tammina Life Science provides a comprehensive suite of outsourced services to ensure compliance across the total lifestyle for a wide range of product types. Tammina Life Science’s in-house Qualified Person Responsible for Pharmacovigilance (QPPVs) and operational team provide a safe-haven for your safety data and our company regulatory life science experts help our clients to remain in compliance and manage their commitments to monitor patient safety. Tammina Life Science uses a fully validated and industry standard database and we have the flexibility and capability to scale our services for small clients with a single clinical trial, through to global multinationals with marked products that create high case volumes requiring 24/7 support.

Services by Tech Tammina Life Science :

Our company regulatory experts provide full pharmacovigilance support for products including innovator products, advanced therapies, and generics. Led by a team of experienced professionals and in-house QPPVs can bend to meet the medical safety needs for an extensive range of product portfolios and provide the services.

Our company regulatory life science experts works on various types of safety reports across the globe mainly in regions like Europe, USA, and Middle East. Reports like Developmental Core Safety Information (DCSI), Periodic Safety Update Report (PSUR),Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS),Periodic Adverse Drug Experience Report (PADERs), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Annual Safety Report (ASRs), any other country-specific reports are done by our company.

To meet your complex global regulatory needs Tammina Life Science offers regional services. Some of the services are –

  • Medical information function.
  • Profile Management EUDRAVigilance.
  • QPPV for European Union-qualified person for pharmacovigilance.
  • National contact persons and In-country pharmacovigilance services.

Advantages for Choosing Tammina Life science:

  • The Pharmacovigilance services we provide can help you perform any curative actions that might be necessary.
  • We use flexible systems and technologies for pharmacovigilance to reach the expectations of our clients.
  • For your complaint and effective pharmacovigilance system, we offer all the components required to help you ensure drug safety.
  • Our Tammina experts have great knowledge and experience of the industry and they work processes of quality control, scientific, editorial and medical reviews.
  • Qualified Person for Pharmacovigilance for Europe can be provided by Tammina. A wide range of Pharmacovigilance services by top specialists to assist the production of Risk Management Plans (RMPs) should be able to be provided by your uniquely placed standard operating procedures and safety data exchange agreements.
  • We also give electronic reporting on an Individual case of safety reports to European Union Drug Regulating Authorities Pharmacovigilance (EUDRAVigilance).
  • We have experts in ICSR case management which include case processing, medical review, narrative writing and quality control and submissions.
  • Strategic services, system setups, and even pharmacovigilance database are provided by our company.
  • Signal detection, ICSR services, Report services, Periodic safety report service, Literature monitoring service, safety monitoring service are some of the services provided by our company regulatory life science expertise.
  • We also work on service data exchange agreement.
  • As per local regulatory requirements in various geographies, we have setup for writing SOPs and training employees, Harmonization, the Pharmacovigilance Database Validations, Pharmacovigilance Database Evaluations and Pharmacovigilance systems and processes.
  • Tammina also helps you in responding to regulatory inquiries.
  • We help you to assist with the assessment of benefits and risks and help you in responding to safety concerns.
  • We also carry out training and have top-class experience in performing audits.
  • We have experienced professionals to track Safety variations and Pharmacovigilance System Master File (PSMF) compliance.
  • Our team has expertise in writing aggregate safety documents as per various health authority and submission requirements likeDevelopmental Core Safety Information (DCSI), Periodic Safety Update Report (PSUR),Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS),Periodic Adverse Drug Experience Report (PADERs), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Annual Safety Report (ASRs), any other country-specific reports, etc.

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