With the help of its well experienced team of pharmaceutical regulatory affairs and scientific professionals, Credent provides a comprehensive regulatory affairs management and support services in the following areas:

• Complete Solutions for Regulatory outsourcing and dossier management service as per regulatory requirements of USFDA, MHRA, EMA, ANVISA Brazil, Health Canada, TGA Australia, WHO, DCGI-CDSCO India, and other regulatory agencies.
• Regulatory Strategy Support, Data review, Regulatory Document preparation and outsourcing support for generic drugs: Abbreviated New Drug Applications (ANDA) including amendment, PAS and CBE supplements and annual reports as per USFDA requirements.
• Regulatory Strategy, Data review, Regulatory Document preparation and outsourcing support for New Drugs and Hybrid formulations from pre-clinical phase and filing of Investigational New Drug Application (INDA) and subsequent clinical phases. Preparation and filing support for New Drug Applications (NDA) and 505 B2 applications as per USFDA requirements.
• Regulatory Strategy and support for filing of regulatory applications in European countries through Centralized Route and Decentralized Route and National applications meeting requirements of EMA,MHRA and other agencies in Europe for generic drugs and new drugs.
• Regulatory Strategy and support for filing of regulatory application dossiers in Canada, Australia, Brazil and India and other health agencies of countries from CIS, South America , Africa, and Asia.
• Regulatory filing in Electronic CTD formats and paper formats as necessary.
• Support in making adequate responses to Regulatory Review Comments in a timely manner.
• Complete Regulatory support for all CMC and Microbiology issues.
• Regulatory Labeling Development and Support.
• Regulatory support for validation issues.
• Coordination, Liaison support with regulatory agencies.
• Training support on wide range of Regulatory Topics including guidelines from various regulatory agencies.