Regulatory Medical Writing

In today’s dynamic regulatory landscape, skilled regulatory medical writing and pharmacovigilance services can add a lot of value to an organization’s overall goal.

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Regulatory Medical Writing

  • Clinical and Non-clinical sections of the Common Technical Document (CTD), including Overviews and Summaries
  • Clinical Study Reports (full, abbreviated, interim, and synoptic)
  • Protocol Development (including synopses and amendments)
  • Investigator’s Brochures (IBs)
  • Prescribing Information (PI), Patient Information Leaflets/ Medication Guide, Summary of Product Characteristics (SmPCs)
  • Company Core Data Sheets (CCDS)
  • Briefing documents for Agency meetings

Vision

To become a noble regulatory consultancy, delivering high quality regulatory support to clients for introduction of wide range of generic and branded products in the market.

Mission

We thrive to provide quality focused and flexible services to the utmost satisfaction of our clients building long-term relationship.

Values

Success and strength of any company rests on its strong beliefs and values. We believe in Customer service excellence, Uncompromising quality, Ethics and integrity

Our Client’s Testimonials

    Manager-Regulatory AffairsHead of Regulatory Affairs
  • Aariya’s seamless support in arranging quality labeling, technical inputs, quality review, and most importantly their short turn-around time helped us in timely response to the FDA thereby assisting in securing faster product approval.
    Manager-Regulatory Affairs
    A Malaysian Based Generic Pharmaceutical Company
  • They are great with their prices and excellent with their turn-around times. The most important quality that I like about Sachin and his team is that they would go that extra mile to get the job done and have so far never let us down.
    Head of Regulatory Affairs
    A US Based Generic Pharmaceutical start-up