Biologics

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 Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparations that are prepared from living organisms and their products for human use. They include serums, vaccines, antigens, antitoxins, etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents.

The registration and approval process is more difficult due to variations in the regulatory criteria for each type of biological/biosimilar product and constantly changing submission requirements of Health Authorities of regulated and emerging markets. It is crucial to have biologics registration services and strategy help from a reputable regulatory affairs partner like RGInsight in order to successfully navigate the challenges and submit products to various markets. 

We are a specialized provider of regulatory services with extensive knowledge managing innovative biologics, biosimilars, vaccines, blood and plasma products, and cellular and gene therapy products across the globe. Complete advice on Regulatory strategy and biologics registration services is available from our experts at RGInsight.