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Pharmacovigilance Consulting, Pharmacovigilance Outsourcing Services Company in India

Pharmacovigilance Consulting

Oviya MedSafe offers comprehensive global pharmacovigilance consulting solutions through regulatory compliance, higher productivity and strategic drug safety outcomes. Oviya MedSafe has the broad-based experience in pharmacovigilance domain to help you address product safety concerns in a confident, proactive manner, and operating experience to provide unparalleled support to our clients.

Standard Operating Procedures, Work Instructions & Guidance Assistance

Generation of well-structured written policies and procedures ensures effective implementation of quality system and demonstrates what the MAH wants to achieve. At Oviya MedSafe, we develop all Pharmacovigilance-related Standard Operating Procedures (SOPs) in compliance with global regulatory requirements safeguarding data integrity and keeping quality standards. We also extend our service by providing guidance with revising and updating existing procedures.

Audit & Inspection Support

The recently released Pharmacovigilance regulations have insisted that all MAH in the EEA to perform regular risk based audits of their Pharmacovigilance system and Quality Management Systems and to communicate any safety risks with regulators and health professionals. The main purpose of a Pharmacovigilance audit is to verify the effectiveness and appropriateness of the Pharmacovigilance system using the objective evidence. The team at Oviya MedSafe offers expert advice and support related to audits and mock inspections to ensure your company is well prepared to manage the risks that have a huge impact to the company’s Pharmacovigilance and Quality management system which might lead to favourable regulatory Pharmacovigilance inspection outcomes.

Training & Consultancy

The rapidly changing regulatory environment further challenges the need for Pharmacovigilance. With consultancy as our core business, we offer to provide comprehensive and up-to-date training to your staff. With strong sense of industrial trends and regulatory expectations, we can help guide you through the strategic planning the earliest stages of setting up the Pharmacovigilance system.

Evolving & Implementing CAPAs

Auditing and inspections help identify the issues in pharmacovigilance system which are either repetitive or non-functional. This in turn necessitates the development and implementation of Corrective and Preventive Action (CAPA). At Oviya MedSafe, our CAPA process ensures we identify the need for CAPA, conduct root cause analysis, closing out the investigations with proper conclusions, implementing and documenting corrective actions, and emphasizing on importance of measuring the effectiveness of CAPA.

Regulatory Safety Assistance

Regulatory safety assistance extends from pre approval submissions to post authorization, global updates to ad hoc regulatory changes and the product life cycle management. We help guide our clients across various stages of regulatory work keeping constant watch over worldwide regulatory updates. Our expert team of regulatory affairs professionals undertake complete regulatory submission services on behalf of its clients.

Expert Clinician Panel Support

It is imperative for drug safety physician to keep tabs on changes in Pharmacovigilance regulations across the globe.Challenging even more is to keep oneself updated on every development across all specialties. Oviya MedSafe proposes a novel solution to this challenge with our Expert Clinician Panel. Consisting of well-qualified, widely experienced medical and surgical specialists in active practice, the panelists provide oversight and value-added assistance to Pharmacovigilance physicians and drug safety associates.

Medical Information – Call Centre Support

Responding to medical information requested from patients and healthcare professionals involves best practice in medical communications. Keeping company’s standards for medical information and monitoring regulatory updates is a step forward responding to inquiries. Oviya MedSafe provides medical information service on behalf of its clients including call centre support. We provide assured services throughout the year or customize them to meet our clients’ requirement.

Pharmacovigilance System Master File Preparation

EU Pharmacovigilance Legislation has made it mandate for MAHs to maintain a Pharmacovigilance System Master File (PSMF). Replacing the DDPS, PSMF now is the key document which outlines company’s pharmacovigilance system. Serving as a tool for QPPV to have an oversight of the PV system, PSMF remains as one of the extensive tasks which address the pharmacovigilance procedures, the safety database, QMS, and business continuity as well as their backups. Oviya MedSafe offers the preparation of the PSMF in accords with GVP.

Pharmacovigilance Database Consulting

Safety database are established to handle medical information that are secure and critical. It is cumbersome to deciding upon a concise database. With the pharmacovigilance industry now mandating to be become E2B and 21 CFR Part 11 compliant, it is of paramount importance to implement and/or upgrade safety database with necessary data migration as business requirements. Oviya MedSafe can consultant you to help understand the important inter-dependencies that exist between aspects of clinical trials and post-marketing surveillance. We assist in determining, validating, and suggesting cost effective selection of database.

Turnkey Projects in Pharmacovigilance

At Oviya MedSafe, we have set industry standards to gear up every project we take up, right from kick-offs to its designated delivery. We have achieved this through our proactive efforts ensuring timely reporting to the clients; make us available 24/7, providing best of our resources. Respecting each needs and the changes, we keep projects running – on time and on budget.

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