Regulatory assessment is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is important at various stages of product development such as: prior to Regulatory submission, during review and approval and post-approval of the product for global markets. Enabling manufacturers to understand the open points to be addressed and prepare the mitigation plan before Regulatory submission for any Pharmaceutical/Biological product, Regulatory assessment minimizes the possible rejections (e.g. Refuse to Receive [RTR]) from Health Authorities (HAs), delays in review cycles with deficiencies and also accelerates the approval processes.


Regulatory assessment/gap analysis play a significant role in various Regulatory submissions such as:

  • Initial submissions – pre-submission meetings
  • Regulatory gap analysis
  • Registered dossier extension
  • Core dossier compilation
  • Legacy product re-launch
  • Lifecycle management
  • Electronic conversions

Freyr Expertise

Initial Submissions

  • Core dossier compilation, preparation of product briefing for new projects (includes Reference Listed Drug [RLD] section, [Inactive Ingredient Guide] IIG clearance/ correspondence with the Food and Drug Administration (FDA), brief on bioequivalence requirement, literature collection pertaining to product, excipient details, packing configuration, guiding about changes in excipients)
  • Guiding for selection of API manufacturer (e.g. based on impurity profile, ICA completeness), section of excipients and packing material suppliers based on requirements for US submission
  • Guidance for selection of API manufacturer
  • DCP slot booking
  • RMS selection
  • Pre-submission meetings
  • Advice for appointment/consultation of Qualified Person Responsible for Pharmacovigilance (QP and QPPV)
  • Consultation of batch release testing site and batch control site
  • Designing of stability protocol, photo stability protocol
  • Designing of hold-time study protocol, process validation protocol, analytical method validation protocol
  • Support for designing pilot batches scale up and commercial batches
  • Support in selection of Dissolution parameters/multimedia/for performance of dissolution for test product and RLD
  • Selection of test product and RLD bio-batch lot for Bio-equivalence study
  • Preparation of bio-waiver for other strengths
  • Design of specification of API, finished product, selection of analytical method based on DMF/ monographs
  • Design/ review of Quality by Design (QbD) protocol and report
  • Review of batch master records, batch packing record
  • Review of analytical validation protocol, hold time protocol, stability protocol
  • Preparation and review of technological transfer protocol and report of analytical method and manufacturing process
  • The USA administrative requirement like establishment registration, self-identification, preassigned submission number, FDA Establishment Identifier (FEI) and Data Universal Numbering System (D-U-N-S) number

Registered Dossier Extension

  • Registered dossier or master dossier extension from
    • Major regulated markets to other major regulated market countries
    • Major regulated markets to emerging countries
  • Registered dossier from emerging markets (Rest of the World - RoW) to major regulated markets
  • Registered dossier from emerging markets to other emerging markets

Legacy Product Relaunch

  • Assessing the correspondence with HA during suspension/withdrawal of application
  • Correspondence with HA for re-activating/re-submission of application
  • Assessing the registered dossier for the content against current country-specific requirements for adequacy, so that gaps remediation shall be performed
  • Route map preparation and guidance for the successful relaunch of the drug product
  • Target country annual revenue details of the product
  • Core dossier compilation and submission along with supporting documents/data to HA
  • Support during review till approval

Lifecycle Management

  • Prior Approval Supplements (PAS)
  • Major Variations (Type II)
  • Amendments
  • Changes Being Effected – 30 (CBE-30)
  • Changes Being Effected (CBE-0)
  • Minor variations (Type IB, Type IA & Type IAIN)
  • Renewals
  • Extension Applications
  • Annual Reports
  • Biannual Updates

Electronic conversion activity

  • Paper DMFs (non-CTD/CTD) into eCTD format for APIs and Excipients
  • Notice to Applicant (NtA) format to eCTD format
  • Paper CEPs into NeeS format
  • Paper INDs into eCTD format
  • Paper MAAs (non-CTD/CTD) into eCTD format

Freyr Advantages

  • Freyr experts have real-time experience in research, analytical, manufacturing and quality control departments is added advantage
  • Regulatory professionals with expertise in Regulatory submissions to determine the exact requirement from each HA to identify the gaps in the source data/documents
  • Regulatory assessment and remediation to reduce the approval timelines