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Regulations related to drug & drug products continue to pose a major challenge for the global pharmaceutical and allied industry. In such situation – a sound regulatory strategy is key to the success of product development and launch or to the success of business entry into specific market.


An effective Regulatory strategy aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team, for the product being developed, by identifying the important regulatory elements to be addressed to market that drug product or medical device.


We, at DDReg, monitor the dynamic regulatory environment and provide an expert, objective perspective on opportunities and challenges for pharmaceutical companies as its clients.


Our services in this area include

  • Registration Strategy in EU & Emerging Markets
  • Regulatory Feasibility Analysis
  • Strategies for product Filing and Variation
  • Advisory on CMC data generation for successful filing
  • Change Control Strategies
  • Subject Matter Expertise
  • Strategy for Query Responses
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