Regulatory Assessment, Gap Analysis, Pharma, Biological products

Regulatory assessment is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is important at various stages of product development such as: prior to Regulatory submission, during review and approval and post-approval of the product for global markets. Enabling manufacturers to understand the open points to be addressed and prepare the mitigation plan before Regulatory submission for any Pharmaceutical/Biological product, Regulatory assessment minimizes the possible rejections (e.g. Refuse to Receive [RTR]) from Health Authorities (HAs), delays in review cycles with deficiencies and accelerates the approval processes.

Regulatory impact assessment/gap analysis play a significant role in various Regulatory submissions such as:

• Initial Submissions

• Registered Dossier Extension

• Legacy Product Re-Launch

• Lifecycle Management

• Electronic Conversions