• Mission Statement

    We know about the interaction of business activities and regulatory requirements of the well regulated segment of pharmaceutical and medical world. A team of experienced experts is available to support your business plans.

    Or maybe you want to outsource the below mentined activities? Get in touch with us and we find a solution for you that lines up with your ideas and business.

  • Regulatory Affairs

    • Development of regulatory strategy for the product’s life cycle

    • Consideration of international regulatory requirements

    • Meeting international fillings

    • Plan revision as guidelines change

    • Dossier/submission preparation or review and filing

    • Facilitate interaction with regulatory agencies, such as in meetings, conferences, negotiations during development stages, submissions and submission approval process

    • Regulatory classification of products across the areas

    • Renewal submissions

    • Provide expert regulatory CMC compliance advice throughout product development

    • Work with the concerned regulatory authorities through the resolution of complex development issues
  • Pharmakovigilance

    • Implementation and Maintenance of PV Systems

    • Regulatory Compliance

    • Trainings

    • Pharmacovigilance Audits

    Quality Management

    • Implementation and Maintenance of QA Systems

    • Training

    • Document Templates

    • GxP and QA Audits

    Business Development

    • Market Feasibility Study

    • In/out Licensing

    • Foundation of local branches/representative offices

    • Identification of distributors and business partners