Medanta’s over-riding aim is to identify and manage safety issues that may emerge after licensing and to protect your product in the market. Medanta has well known senior pharmacovigilance staff with an extra-ordinary breadth and depth of expertise with the FDA, EMEA and EU Competent Authorities. Changes in the regulatory environment mean that there has never been a more critical time to have the highest possible standards in pharmacovigilance available to your company and your products. Medanta can deliver a pharmacovigilance service tailored to your needs; from individual case management through to providing your pharmacovigilance department in its entirety. Our services include:

Design, implementation and provision of a global, regulatory-compliant pharmacovigilance system supported by full documentation and SOPs;

Management of ICSRs from all sources;

Provision of a central “hot-line” telephone number and e-fax capability;

ICSR receipt, data entry, triage, MedDRA coding, narrative writing, medical review, quality control and reporting of cases to agencies;

Literature search and review;

Registration of your company with EudraVigilance Post-authorisation module;

Provision of the European QP for pharmacovigilance and deputy with comprehensive 24-hour on-call facilities;

Signal generation, detection and trend analysis using our proprietary technology (PV-Trends™);

Preparation and submission of PSURs and PADERs;

Preparation of risk management plans;

Design and implementation of risk minimisation activities; e.g. PASS and patient registries;

Managing interactions with third-party organisations and commercial partners;

Benefit/risk assessment and management of safety issues;

Representation and negotiation with regulatory agencies;

Preparation for agency pharmacovigilance inspection;

Auditing of pharmacovigilance systems, including pre-inspection audits.