Russia Regulatory Compliance Requirements for Life Science Products

Life sciences companies across the globe are witness massive changes. Evolving regulations, rising stakeholder expectations, shifting demographics, emerging science and changing business models have made compliance and risk management all the more challenging.

As the world is becoming mutually dependent on each other, there has been an expansion in Global Clinical Research, and corresponding growth in the market for biologics, medical devices, combination products and pharmaceuticals. The cost and time required to bring fresh products to the market remains a major challenge for the company’s balance sheets and budgets. Although, it is essential to have a robust channel for new patented products, global producers have been analyzing the best methods to start participating in emerging markets.

Russia is being seen as an emerging market for global life science products. Many manufacturers are finding it advantegous to provide innovative products to these bigger patient population areas, especially with products with existing country licenses and expanding it to countries like Russia. There is better foreign access at present, as the global standards among provincial government agencies have aligned and removed the usual conflicting standards. The regulatory systems procedures and requirements and the healthcare authorities are clearer for industry partners and clinical trials can be done at low costs.

The Rx and OTC pharmaceutical products and Medical Devices products are believed to grow in this considerable untapped Russian market; there is more structured healthcare systems and insurance coverage in the emerging markets.

In the recent years, there has been a lot of improvement in Russia in regards to their regulatory management that governs the Life Science Products and the food industry; however, some hurdles still remain. Thanks to their GLP, GSP, GMP, GCP and other regulations, their policies have been better aligned with the international standards of practice, which is contributing to the growth in Russia for fresh and already licensed products. The Russian Life Science Products distributors and manufacturers should pay good attention to the pace at which the changes are being implemented by healthcare agencies and they should use this knowledge to adjust their standard operating procedures accordingly to ensure compliance with the evolving regimes.

Join this comprehensive 3-hour Live Webinar by expert speaker Robert J. Russell on Regulatory Compliance Requirements for Life Science Products in Russia to get a deeper and accurate understanding of procedures, policies and requirements for pharmaceuticals, medical devices, combination products and biologics. This in-depth session will go through the clinical and pre-clinical requirements and the structure of regulatory agencies.

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