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.

Our Services

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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News

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World Drug Safety Congress Americas, Oct 29-30, 2024

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World Drug Safety Congress Europe, Oct 09-10, 2024

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DIA Global Annual Meeting, Jun 16-20, 2024

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DIA Europe, Mar 12-14, 2024

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DIA Global Pharmacovigilance and Risk Management Strategies...

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CPHI, Barcelona, Oct 24-26, 2023

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World Drug Safety Congress Americas, Oct 18-19, 2023

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DIA 2023, Global Annual Meeting Jun 25-29, 2023

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DIA Europe 2023, Advancing Health Priorities Mar 22-24, 2023

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DIA Global Pharmacovigilance and Risk Management Strategies...

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Webinar: RMPs and REMS: Comprehending the inscrutable

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Webinar: DSURs: Nuances and Beyond

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World Drug Safety Congress Americas, Oct 04-05, 2022

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DIA Global Annual Meeting, Jun 19-23, 2022

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ASCO Annual Meeting, Jun 03-07, 2022

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Webinar: Post approval pregnancy safety studies: Challenges...

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Webinar: CTFG guidance for Reference Safety Information: Whe...

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Webinar: PADERs and PSURs: Nuances and beyond

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Webinar: Management of Development Safety Update Report: Unr...

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DIA 2021 Global Annual Meeting Jun 27- Jul 01, 2021, Virtual

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Webinar: Pharmacovigilance and medical monitoring on a globa...

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Webinar: Imprints of COVID 19 pandemic on global regulations...

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Webinar: Insights into RMPs and REMS: New regulatory perspec...

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Webinar: Global regulatory perspective on vaccine pharmacovi...

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World Drug Safety Congress Americas Sep 1-2, 2020, Virtual

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Webinar: Management of REMS and RMPs

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Webinar: Update on the changing dynamics of pharmacovigilanc...

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DIA Europe 2020, Brussels, Belgium, Jun 29- Jul 03, 2020, Vi...

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DIA Global Annual Meeting, Jun 14-18, 2020, Virtual

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Webinar: Management of vaccine pharmacovigilance: Global Reg...

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Pharmacovigilance and Risk Management Strategies Conference,...

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Indian and European Regulatory and Quality summit, The Park,...

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Webinar: Safety management and medical monitoring in global...

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Pharmacovigilance conference 2019 by Virtue Insight in Bosto...

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JOIN OUR LEADERSHIP TEAM AT DIA 2019 GLOBAL ANNUAL MEETING,...

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DIA Pharmacovigilance and Risk Management Meeting; Washingto...

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DIA 2018 Annual Meeting, Boston; June 24-28, June 2018

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AWINSA to go live with the latest version of Argus to provid...

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DIA Annual Canadian Meeting in Ottawa - 31, Oct 2018

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Strengths of AWINSA

Awinsa

Leading-edge scientific capabilities

  • Leading scientific resources, with a wealth of expertise accumulated over decades, and supported by a comprehensive team of dedicated Physicians and other health care professionals.
  • Wide-ranging proficiency in a variety of healthcare products, such as Drugs, Medical devices, Vaccines, Biologicals, Biosimilars, Genetic Therapies and Hybrid products.
  • Expertise in crafting medical and scientific content crucial for the worldwide approval of products and compliance with post marketing needs.
Awinsa

Client-Centric Approach

  • Comprehensive support offered in Pharmacovigilance and Medical affairs services covering the entirety of the product's lifecycle.
  • Highly scalable and adaptable models of operation tailored to meet our clients' needs.
  • Strong management system characterized by a cooperative strategy to ensure effective partnerships.
  • Engagements designed to be results-oriented, ensuring clients achieve their desired outcomes.
Awinsa

Global Operations

  • Presence in US, Europe, and Asia
  • Safety reporting capabilities in 60+ countries
  • Active in the creation and enhancement of regulatory strategies for sustaining international regulatory compliance.

Expertise where it counts

ICSRs
70000+

ICSRs

RMPs
100+

RMPs

safety
1000+

Safety Signals

1200+

Aggregate Reports

700+

Literature Survillence

Video Library

Auditing Services - Dr. Mugdha Chopra

Risk Management Plans - Dr. Sanjeev Miglani

Signal Management - Dr. Sanjeev Miglani

Case processing

Management of Aggregate reports - Dr. Mugdha Chopra

Risk Managment Plans

Impact of E2B R3 related changes on MAHs - Dr. Mugdha Chopra

Signal Evaluation & Management: "The Pillar of Patient Safety"

Medical Monitoring Services - Dr. Sanjeev Miglani

Testimonial

AWINSA team consistently goes above and beyond to fulfil their commitments. They always deliver flawlessly and never disappoint; We are proud to collaborate with them

Senior Director Pharmacovigilance

Large size US Pharma

We cannot express enough gratitude for the exceptional support you have given us. It is clear we couldn't have accomplished this without your input. Your team's commitment, prompt actions, and expertise are highly valued. Thank you for continuing to stand by us.

Senior Vice president Clinical development

Mid-size US biotech Company

Ever since we started leveraging AWINSA's Pharmacovigilance services, I've been able to sleep peacefully. The team at AWINSA consistently delivers top-notch work.

Chief Medical Officer

Mid-size US Pharma Company