Awinsa Life Sciences @AWINSALS

Medical devices and drug–device combos need a unique approach to safety oversight. With dual reporting under MDR (21 CFR 803/806/814.84) and drug rules (21 CFR 314.80), compliance is complex. At AWINSA Life Sciences, we help clients integrate reporting to ensure safety. #AWINSA

Second-generation antipsychotics offer a promising alternative to first-gen meds, but their link to extrapyramidal symptoms (EPS) is crucial. Explore how these modern drugs balance efficacy and EPS risks through clinical studies and expert insights.... awinsals.com/whitepapers-de…

Managing safety data exchange agreements and ensuring compliance can be a significant challenge for global pharmaceutical companies with intercontinental operations. Experts at AWINSA can help streamline the process.

EU-MDR reshapes device safety: stronger PV systems, continuous surveillance & robust vigilance reporting are now essential. AWINSA partners with manufacturers to deliver compliance & patient safety. Read more in our white paper: Ensuring EU-MDR Compliance. awinsals.com/whitepapers-de…

Happy Labor Day! Celebrating equal opportunity, mutual respect, and improved working conditions across the globe. #AWINSA #Pharmacovigilance #DrugSafety #DrugDiscovery #LaborDayUSA

FDA mandates post-approval monitoring for pregnancy & lactation: exposure registries, RWD, lactation studies & PLLR updates. AWINSA Life Sciences supports sponsors with registry design, PV integration & labeling accuracy safeguarding mothers & infants. awinsals.com/whitepapers-de…

SDEAs keep safety data flowing smoothly between partners, avoiding delays, gaps, or risks to patients. At AWINSA Life Sciences, we help draft, review, and implement SDEAs for clear roles, efficient communication, and compliance. #AWINSA #PV #DrugSafety #Drugdiscovery

Reliable trials need solid data and patient safety. At AWINSA Life Sciences, our medical monitoring ensures protocol validation, real-time safety review, and accurate benefit–risk reporting, keeping science and patients first. #AWINSA #Pharmacovigilance #Drugsafety #Drugdiscovery

Respiratory trials pose unique safety challenges, flare-ups vs. treatment effects, device risks, long-term steroid use. At AWINSA Life Sciences, we blend pharmacovigilance & medical monitoring to detect true signals, guide endpoints, and ensure global compliance. #Awinsa #PV

To revamp your knowledge on the modus operandi of risk management, watch our webinar on “RMPs and REMS: Comprehending the inscrutable” #AWINSA #Pharmacovigilance #RMP #REMS youtube.com/watch?v=b8S1C9…

EMA recently released Addendum II to GVP Module VI—updated guidance on personal data masking in ICSRs for EudraVigilance, aligning with GDPR. At AWINSA, we help MAHs & CROs stay compliant with evolving PV rules through expert support in systems, SOPs, privacy & training. #AWINSA

Risk Management Plan (RMP) in the EU and Risk Evaluation and Mitigation Strategy (REMS) in the USA are now a standard part of pharmacovigilance. Learn more from Dr Sanjeev Miglani, MD about his views on RMP and its recent updates in EU regulations. youtube.com/watch?v=alPWaB…

Honoring 78 years of India’s independence—a legacy of courage, unity & vision. At AWINSA, we’re committed to a future of innovation, integrity & collaboration. Wishing all a proud & inspiring Independence Day! #AWINSA #IndependenceDay #Pharmacovigilance

Needless to say, sound knowledge and insight coupled with the right tools and procedures are critical for the success of your RMP. Read on to find out how AWINSA helps you to nail it. youtu.be/15ySw0Tvz0s

Recognizing the critical importance of diligent pharmacovigilance for Autoimmune diseases, AWINSA Life Sciences was selected as the strategic partner to oversee this initiative. View more.. #AWINSA #Pharmacovigilance #DrugSafety #DrugDiscovery awinsals.com/case-details/a…

From ALS to Alzheimer’s, neurology trials face unique safety challenges. AWINSA Life Sciences delivers tailored PV oversight, risk management & global compliance to protect patients and drive trial success.

Navigating the complexities of marketing authorization applications? At AWINSA, with a dedicated team adept in pharmaceutical risk management strategies, we ensure your drug application journey is efficient and aligned with safety protocols.

Pregnancy safety studies are crucial for understanding how medications impact fetal-maternal outcomes. Learn from our webinar how AWINSA integrates clinical expertise and FDA guidelines to tackle challenges and enhance treatment and counseling. Watch now: youtube.com/watch?v=Q-vOmB…

ICH E2D(R1) draft (Feb 2024) marks a leap in ICSR reporting: modernizing definitions, expanding scope, and driving global harmonization. AWINSA Life Sciences enables seamless compliance through expert PV support and smart automation.

At AWINSA Life Sciences, we specialize in pharmacovigilance strategies that help identify, monitor, and manage hepatic safety concerns, from pre-clinical assessments to real-world data monitoring.