About Envistream Regulatory
We at Envistream Smartech, offering the regulatory update & Intelligence services to Lifescience, Healthcare & Pharma industries to act on this actionable intelligence and execute their operation and businesses.
Our Regulatory Intelligence, providing regulatory updates, changes and discuss on its impact on the current regulations and best practices on Pharmacovigilance, Clinical Research, Regulatory Affairs, Healthcare and Medical affairs domains. Our regulatory update service is accurate and concise and directly from medicine agencies or Government authorities.
Our experts are keep watching, monitoring & evaluating the valuable piece of regulatory & compliance update information through system and update it to Pharma & healthcare professionals as soon as possible. Therefore, the actionable intelligence would be prepared in quick turn around and the changes of rules & regulations would be tracked, mapped and implemented by Pharma industries.
Regulatory intelligence is the monitoring, gathering and analyzing of new information into actionable items to ensure an organization’s success. Regulatory Compliance is when a business track the changes of law, policies and regulations relevant to its operations.
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About Envistream Smartech
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AZD7442 antibody combination reduces COVID-19 risk by 50 percent
Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca’s AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised...
Influenza vaccine with COVID-19 booster shot shows positive results
Sanofi has announced positive data from the first study of their high-dose influenza vaccine with a COVID-19 messenger RNA (mRNA) booster shot. Interim results from the first co-administration descriptive study of Sanofi’s Fluzone® High-Dose Quadrivalent vaccine with...
Spine devices, recalls and endovascular stents on FDA’s fall meeting lineup
FDA's fall meeting lineup includes a roster that could impact a broad swath of the medtech industry, with sessions on evidence for spinal devices, how recalls are communicated, the safety of endovascular stents and artificial intelligence technology. Like last...
COVID-19 seems to skew Abbott heart failure monitor study results
A clinical trial evaluating the effectiveness of Abbott Laboratories' implantable heart failure monitor in an expanded patient population missed its primary endpoint, but a pre-COVID-19 impact analysis showed a potential benefit in reducing hospitalizations for...
Bharat Biotech’s Suchitra Ella says vaccines shouldn’t be a barrier to enter any nation if approved by national regulatory authorities
Vaccines should not become a barrier to enter any nation, Suchitra Ella, Joint managing director, Bharat Biotech said on Tuesday as the UK declared that fully vaccinated Indians travelling to the UK will be treated as unvaccinated. She said those vaccines which are...
Merck asks US FDA to authorize promising anti-COVID pill
Drugmaker Merck NSE 0.23 % asked U.S. regulators Monday to authorize its pill against COVID-19 in what would add an entirely new and easy-to-use weapon to the world's arsenal against the pandemic. If cleared by the Food and Drug Administration, a decision...
