Overview
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