NDA Regulatory Services

NDA Regulatory Services – [NDA] New drug Approval process in USA in 2020

Although all countries have a different regulatory procedure for new drug approval and market a particular drug worldwide, the drug has to pass through the Marketing Authorization Application (MAA) of different countries. As USA plays an essential role worldwide in distribution and marketing drugs, one should know NDA Regulatory Services and its rules in USA.…

combination of drug product development

Facts About Combination Drug Products and Their Developments

Introduction: The diagnostic products, including drugs, devices, and biological products, are commonly referred to as Combination drug products. Combination products generally contain components that are typically regulated by different types of regulatory authorities. These products also face different kinds of challenges by various FDA centers regarding regulation, policy, and review management. The regulatory processes can…

Pharmacovigilance consultants

Pharmacovigilance Consultants – a Consultant Service for Medical Products

Medical products, even though the solution to many ills, have also been revealed as a possible source of adverse events or side effects. The role of Pharmacovigilance consultants is the recognition of drug or device risks, whether caused by quality defects, by intrinsic toxicity of the product, by idiosyncratic reactions of the individual, or by…