IND, NDA, ANDA, BLA, NDA, Submissions, Applications

Freyr specializes in Dossier strategy, Dossier Gap Analysis, Dossier Compilation, Regulatory Content Authoring, Validation and final submission of various global new product authorization applications. Freyr has an established Center of Excellence in this space, and is a preferred partner to more than 50+ API / bulk drug manufacturing clients, globally. A few application types, where Freyr Regulatory Affairs team have expertise, are listed below.

• Investigational New Drug (IND Submissions) both for Pharmaceutical and Biological products

• Clinical Trial Application (CTA)

• New Drug Application (NDA Submission)

• New Drug Application (505 b(2))

• Biological License Application (BLA)

• Abbreviated New Drug Application (ANDA) in line with Refuse to Receive (RTR) and GDUFA II requirements

• Investigational Medicinal Product Dossier (IMPD)

• Marketing Authorization Application (MAAs) to Europe Via Centralised (CP) or National (NP) or Mutual Recognition (MCP) or Decentralised procedures (DCP)

• MAAs for Australia and New Zealand

• New Drug Submission (NDS)

• Abbreviated New Drug Submission (ANDS)

• Dossiers for emerging countries ( LATAM - Latin America, MENA - Middle East and North Africa, APAC - Asia-Pacific, ASEAN - Association of Southeast Asian Nations, SA-SSA - South Africa Social Security Agency and CIS - Commonwealth of Independent Nations )