New Product Authorizations

Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than Aariya.

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New Product Authorizations

A well-prepared regulatory application can translate into a smoother approval process and faster entry to the market. AARIYA has a globally recognized Center of Excellence in this space with expertise in regulatory content authoring, review and compilation of:

  • Investigational New Drug (IND) Application
  • 505 (b)(2) New Drug Application (NDAs)
  • Biological License Application (BLA)
  • Abbreviated New Drug Application (ANDA)
  • Abbreviated New Drug Submission (ANDS) for Health Canada
  • Marketing Authorization Application (MAA) to Europe via Centralized Procedure (CP) or National Procedure (NP) or Mutual Recognition Procedure (MCP) or Decentralized Procedure (DCP)
  • Article 10(4) Application via Centralized procedure for Biosimilars with EEA
  • Marketing Authorization Application (MAA) for Australia and New Zealand
  • Dossiers for emerging countries [South Africa (SA), Russia and Commonwealth of Independent Nations (CIS), Latin America (LATAM), Middle East and North Africa (MENA), Asia-Pacific (APAC), Association of Southeast Asian Nations (ASEAN) and World Health Organization (WHO)]
  • Drugs, Cosmetics and Medical Devices and Food Registration in India


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