Welcome to AWINSA. We are a committed team of experienced professionals from the pharmaceutical sector, focused on providing flexible, innovative, scalable and cost-effective solutions to meet your unique business requirements in pharmacovigilance, clinical safety, medical writing, medical monitoring, and medical affairs. AWINSA is the go-to partner for pharmaceutical and biotech companies seeking compliance and adverse event reporting solutions throughout the drug lifecycle. Our global team of healthcare experts and physicians combines therapeutic, and clinical knowledge to support pharmaceutical and biotechnology companies in developing safe drugs, medical devices, vaccines, and advanced therapies.
Intricate and deep-rooted knowledge of the subject and the international regulations will ensure that you are delivered services of the highest order within the stringent timelines. Filled with passion and an indefatigable attitude at AWINSA Life Sciences, we envision unparalleled solutions to all your requirements thus ensuring the safe and efficacious use of the drugs for society.
ICSR is a report that contains information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual...
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The Council for International Organizations of Medical Sciences (CIOMS), defines a safety signal as "information that arises from one or multiple sources (including observations or experiments),...
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A Standard operating procedure is a document that discusses the activities essential to perform the tasks in compliance with regulatory requirements. They not only throw light...
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Keeping abreast with the ever-changing global regulatory requirements is quintessential for the success of any pharma facility because we cannot do today's job with yesterday's methods...
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Our Medical Monitoring services at AWINSA start before the study starts. The medical monitors help in reviewing some documents like IBs, protocols, CRF, DSMB charter and...
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AWINSA's team is well equipped with experienced healthcare professionals who ensure very high-quality services in Medical Information which include: Global & Multilingual Support MI / AE /...
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Taking emerging adverse events in its ambit, Aggregate reports (PSURs/PBRERs/DSURs) aim to provide a comprehensive and critical analysis of the risk-benefit balance of the product. They...
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All applications for marketing authorization in the EU must include a detailed and complex Risk Management Plan (RMP). RMP includes information on Drug safety profile How...
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The recently released Pharmacovigilance regulations have insisted that all MAH in the EEA to perform regular risk-base audits of their Pharmacovigilance system and Quality Management Systems...
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EEA mandates that a qualified person should be positioned in EU by MAH who will oversee the Pharmacovigilance functions of the company. QPPV is expected to...
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Medical writing is an indispensable part of the pharmaceutical industry as it requires specialized knowledge and skills to present the desired scientific information in a well-structured...
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The heightened disease prevalence has globally stimulated life science companies to match it by augmenting the number of clinical trials. In the background of a stringent...
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ICSRs
RMPs
Safety Signals
Aggregate Reports
Literature Survillence
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59 E,Shrewsbury Place
Princeton, NJ 08540
United States
E13/9 First floor, Vasant Vihar,
New Delhi 110057
Wilhelmina Druckerlaan 10,
6532 SR,
Nijmegen,
The Netherlands
Cerrada Ahuizotla 53,
Col. Santiago Ahuizotla,
Del. Azcapotzalco
CP.02750
Ciudad de México, México.
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