Overview

To commercialize a product in a specific region, organizations must obtain market authorization from target country’s Health Authority (HA), which can be processed by filing an initial submission application (viz. Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Clinical Trial Application (CTA) and other regional applications etc.). Any application of a drug or other products submitted to a HA for the first time, with supporting documents/data in-line with geo-specific requirements, is considered as new/initial/original submission. As submission requirements are dynamic in nature and are frequently updated by HAs worldwide, the need of the hour is to track them in a continuous manner. In such scenarios, organizations opt for Regulatory Affairs to decode and understand region-specific requirements for error-free initial submissions and quick market authorizations.

Freyr is a preferred Regulatory Affairs partner for new market authorizations / initial submissions to global clients, for all types of products (New Chemical Entity (NCE) / New Biological Entity (NBE), Generics / Biosimilars, Medical Devices, Active Pharmaceutical Ingredient (API) / Bulk Drugs, Over the Counter (OTC) / Consumer Healthcare products) and formulations (solid oral, liquid oral, parenteral dosage forms, biologicals etc.). Freyr has a very strong Regulatory team having prior experience and expertise in handling market authorizations of all major HAs like, the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the Therapeutic Products Database (TPD), the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA), Medsafe, the Medicines Control Council (MCC), Ministry of Health (MoH) of Russia, Latin America (LATAM), Middle East and North Africa (MENA), Asia Pacific (APAC), Association of Southeast Asian Nations (ASEAN), Commonwealth of Independent States (CIS) regions, and World Health Organization (WHO).

 

Freyr Expertise

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) both for Pharmaceutical and Biological products
  • Clinical Trial Application (CTA)
  • New Drug Application (NDA)
  • 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 )

Freyr Regulatory Consultation and Pre-Submission Support (Sample activities / expertise)

  • Support during product development. For example, controlled correspondence submission for Q1/Q2 compliance for sterile products or for IIG clearance in case of solid oral dosage forms
  • Specification designing for starting materials, raw materials, excipients, packing materials, in-process intermediates, drug substances and finished products
  • Submission of batch documents finalization like stability protocol, process validation protocol, hold time study protocol, photostability protocol, thermal cycling and thermal excursion study protocols, dilution and microbial dilution study protocols in case of sterile products
  • Gap analysis of submission batch documents
  • US / Canada / Other Global HA representation and Agent Services
  • Pre-assigned ANDA number request
  • Labeling and Artwork Pack Management
  • Establishment registration and self-identification i.e. DUNS number, FEI number request, labeler code request etc. (Form 2656, Form 2657 in electronic format)
  • ANDA eCTD publishing as per current guidelines and requirements
  • Addressing HA queries in stipulated timeframe which impacts approval of the product in specified time
 

Freyr Advantages

  • Experienced Regulatory professionals to provide end-to-end Regulatory support from the development stage to registrations and approvals for drugs and other products
  • Expertise in handling pre-submission administrative activities
  • Regulatory submission strategies for product rollouts and expansions to other regions
  • Regulatory professionals with experience in compilation and submission
  • Accurate scientific justifications for HA query responses