Additional Pharmacovigilance

In line with Article 57(2) regulation of the European Union, Marketing Authorization Holders (MAH) are required to maintain a repository of its medicinal and investigational products and submit product details via electronic message to European Medicines Agency (EMA). Our expert team is proficient in using the data entry tool developed by EMA for small and medium sized organizations. We are also competent in handling leading industry tools along with customization and development of tool for submission of product details via electronic format. Our experts can efficiently handle the transition from eXtended Eudravigilance Medicinal Product Dictionary to Identification of Medicinal Products (IDMP) to relieve Sponsors from the stress of changing regulations and adaptation of IDMP by regulatory agencies.

European Medicines Agency (EMA) has extended controlled access to various stakeholders to its safety data repository to enable better safety monitoring, signal detection and its evaluation. Marketing Authorization Holders (MAH) are required by regulation to include the data archived in EudraVigilance database on a regular basis. We are expert at devising a pragmatic filters and systematic download schedules that will assist MAH to effectively manage workload and reduce costs while maintaining compliance to regulations. We also offer tailored services to across the spectrum of process of EudraVigilance downloads. Our experts are also proficient in accessing and management downloads from other Health Authorities like Health Canada and United States Food and Drug Administration.

Pharmacovigilance processes have become complex and demanding due to changing regulatory framework which are monitored with audits and inspections to impact on quality and compliance of safety data and its systems. With strong domain knowledge in Pharmacovigilance (PV) and good knowledge of Quality Management System (QMS) our experts can extend support our customer during audits to minimize their risk. We also offer auditing as a service with focus on follow-ups and timely coordination for including regulatory audits, partner audits and affiliate audit. Our audit readiness program will help our customers to become more confident in their PV process and maintain highest standards of quality and compliance to regulatory requirements.

Pharmacovigilance (PV) systems are a set of complex operations that impeccably function together to minimize risk and maximize patient safety. Diverse and every updating regulation has made it very difficult for pharmaceutical organizations develop and operate a PV system. With Good Pharmacovigilance Practice as backbone of our processes we offer comprehensive pharmacovigilance services that cater to pharmaceutical organizations of all proportions. We have proven capabilities in the broad spectrum of PV services and good understanding of global and local drug safety requirements that empowers us rapidly scale up for complete pharmacovigilance delivery and set new industry benchmarks in quality and compliance.

Qualified Person for Pharmacovigilance (QPPV) is critical resource in establishment and smooth functioning Pharmacovigilance (PV) system. Marketing Authorization Holder (MAH) are obliged under the European Union (EU) legal framework to appoint a QPPV for initiation and oversight of PV activities. Many countries need a local or regional responsible person for pharmacovigilance at country level to comply with local regulations. Not only do we provide expert services for EU QPPV and local QPPV requirements that guarantee our clients are equipped with the right resources to be compliant with regulations we also offer tailored services to understand which countries require local QPPV and manage cost-effective recruitment.

Pharmacovigilance System Master File (PSMF) is essential document required to be developed and maintained by applicants and Marketing Authorization Holders (MAH) that describes the complete operating structure of its pharmacovigilance (PV) system. Our experts have sound knowledge of Good Pharmacovigilance (GVP) Modules II and proficient in developing structure and content for PSMF that comply with regulations. Our detail-oriented processes enable us to meticulously included all details of the PV systems in a clear, concise and unambiguous manner along with tracking periodic changes and updating the PSMF and its Annexures promptly. Our experts are proficient in both traditional and new tools (ePSMF) for authoring, updating and maintaining of PSMF.

Safety Data Exchange Agreements (SDEA) are usually contracts between licensing / commercial partners and Marketing Authorization Holders (MAH) that details the handling and exchange of safety information to ensure either party comply with legal obligations for safety handling and submissions. We are experts in development of SDEA templates that ensures all factors affecting safety data exchange are effortlessly captured to comply with regulations. We can support our client with drafting and reviewing of SDEAs along with negotiating with partners, reconciliation of exchanged safety data, tracking of effective documents and revision. We also provide critical insights in identifying gaps and interdependencies in PV system that affect SDEA and PV process compliance.

Safety database is an electronic repository that enables collection, processing and submission of individual Case Safety Reports (ICSR) along with facilitating analysis for aggregate, signal and other safety reports. It is a core component of PV System that should fulfill regulatory validation standards along with being periodically updated to comply with changing regulations and updating dictionaries. With vast experience and expertise, we can help our customer choose the precise Safety Database and validation protocols for their requirements that will reduce implementation and maintenance costs. We also advise on interoperability, hosting models and compatibility within existing setup. We are experts in planning, executing, review and release of periodic dictionary upgrades along with offering hosting as a service.

Acquisitions, divestment, technology upgrade and organizational change mandate migration of data from all safety domains. Our experts carefully analyze the source and target to establish the prerequisites and requirements forming a mapping to enable seamless safety data migration. Our prudent validations checks enable us to advise our customers on the right strategy, tools and techniques to meet regulatory compliance, achieve best quality, data integrity and security. We can also assist in conducting migration of safety data for Individual Case Safety Reports (ICSR) from various sources like databases, listings and documents along with identification and migrations of aggregate reports, signal reports, medicinal product details and other safety reports.

Medical and scientific literature is a vital source of safety data for identifying risk and maintaining safety profile of the drug. Varying regulatory requirement for literature surveillance baffle pharmaceutical organizations and put them at risk of noncompliance. Within the array of our literature services, we support of client with translation of literature from foreign languages within short during our time with high level of accuracy. We handle procurement of full text articles to meet our customers literature surveillance requirements for Individual Case Safety Reports (ICSR), aggregate reports, signal reports and other safety reports. We offer expert advice in understating local literature requirement and extend our support in local literature search and procurement of local literature articles.