Regulatory Services

Local and international regulatory affairs are the prime requests through all phases of the drug-development process. Fulfilling the necessary regulatory requirements is the first step towards successful launching of pharmaceutical, cosmetic, and biotechnological products and devices. Global Scientific R@D Pvt. Ltd. offers comprehensive and extensive industry experience shaping project plans to meet diverse local and international regulatory requirements. We are highly efficient in designing strategies for your product, from bioanalytical study requirements, pre-clinical/clinical meetings with the local and international regulatory bodies, and applications to Competent Authorities and Ethics Committees, while providing the necessary guidance to ensure continual regulatory compliance.

We always remain updated with the local and international regulatory requirements as they evolve. Our intelligent and careful counseling always helpful in avoiding unnecessary delay in approval of applications. Global Scientific R@D Pvt. Ltd. Provides the following regulatory services.

  • Training and insights about local regulatory requirements
  • Facilitating the transitions of investigational drugs from exploratory to confirmatory stages
  • Facilitating the submissions for possible acceleration of the developmental process
  • Facilitating the application approval for conducting clinical trials of new drugs
  • Help in addressing the regulatory body requests for information
  • Support for and participation in meetings with regulatory bodies
  • Protocol development and assessment: We offer a systematic approach integrating advanced analytics, therapeutic expertise and real-world data that can substantially improve planning, feasibility and enrollment targets. Thus, we develop or optimize a protocol design to deliver the right data from the start, without unexpected issues or unnecessary costs.
  • We always remain updated with the local and international regulatory requirements as they evolve. Our intelligent and careful counseling always helpful in avoiding unnecessary delay in approval of applications. Global Scientific R@D Pvt. Ltd. Provides the following regulatory services.