Overview

As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and usage of medicinal products, being compliant with stringent requirements is becoming a challenging issue for product registrations and drug approvals. That triggers the need for well-defined Regulatory strategies right from the product development to lifecycle management to addressing all submission requirements, and to comply with the mandatory requirements.

  • Strategic planning for a global clinical trial during development of a product
  • Strategic planning for entering various regions across the globe
  • Strategic planning to take the products approved in one region to other Regulated markets (for example, the USA to Europe or vice versa)
  • Stability study planning for all possible presentations / container closure system
  • Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route maps
  • Switchover from paper format to electronic Common Technical Document (eCTD) submission

Without sufficient understanding on right Regulatory strategy for specific cases, many companies face delays in product registration that affect the costs. Therefore, right partner for strategic planning and monitoring Regulatory changes is the key for successful commercialization of a drug product. With a proven track record to keep abreast with global market conditions and navigating clients across through their unique Regulatory requirements, Freyr stands a preferred Regulatory strategic partner for any Pharmaceutical or Biotechnology company.

 

Freyr Expertise

Regulatory Strategies:

  • Preparation and submission of dossiers (Investigational New Drugs [INDs], New Drug Applications [NDAs], Abbreviated New Drug Applications [ANDAs], Marketing Authorization Applications [MAAs], New Drug Submission [NDS], Abbreviated New Drug Submission [ANDS], Drug Master File [DMF], Active Substance Master File [ASMF], Investigational Medicinal Product Dossier [IMPD]) for new and generic drugs
  • Preparation and submission of Biological License Applications (BLAs)/ MAAs for recombinant therapeutic proteins, vaccines and other biological products
  • Commercialization of advanced therapy products such as stem cells and cell-culture-based products
  • Drug launch from one market to another market
  • eCTD conversions and baseline submissions
  • Implementation of post approval changes
  • Identifying right strategies and mitigation plans for each case
  • Pre-submission interactions with HAs
  • Competitors landscape evaluation and preparation of right Regulatory strategies that suit well for product registrations ahead
  • Identification of right approach for each case / clinical program/ marketing authorization strategies
  • Support for Orphan Drug Designation (ODD) applications
  • Product evaluation for suitability under expedited programs, and Regulatory support for submission of expedited program requests
  • Identification of Regulatory route map for submission information about process, methods and other advanced technologies (e.g. gene sequencing techniques) that are proprietary in nature
  • Change in formulation / route of administration of drugs and the registration of dossier to Health Authorities (HAs) (for example, 505b (2), hybrid applications etc.).

Regulatory Consultation:

  • Quality by Design (QbD) protocols and reports
  • Evaluation of excipients against IIG data base
  • Protocols/ reports for process validation, method validations, specifications, test methods, exhibit batch protocols, pilot scale batches, commercial batch protocols etc.
  • Defining the tests/ risk assessment for genotoxic impurities, elemental impurities
  • Stability study requirements considering bracketing and matrixing concepts
  • Reference Listed Drug (RLD) selection
  • Identifying the submission process in Europe
  • Selection of dissolution parameters multimedia
  • Support in RMS selection
  • Providing response to HA queries
 

Freyr Advantages

  • Professionals with complete understanding of Regulatory guidelines and directives
  • Intelligence that impacts client’s Regulatory submissions as and when required
  • Road map for the products already registered with one HA to register with other HA to enhance business
  • Post-approval changes submission strategy for the proposed changes to maintain the compliance and to submit Supplement/Variation/Amendment to minimize the manufacturing/Regulatory cost to client and for quicker approval