Generics Manufacturers

Maximize your profit on Generic Portfolio From development to measurement and expansion, Fervor is your partner every step of the way. Leverage services and tools optimized for generics manufacturers, all backed by the power and knowledge of our experts.

Development Stage

Quality by Design (QbD) Protocol & Product Development Report Review
Review Guidance in Stability Protocol, Hold Time Protocol, Process Validation Protocol and Master Formula Record
Support in Finalization of In-process and Finished product Specifications and Test Methods
All Method Validation and Verification/Transfer Reports
Guidance on Bio study, Stability Study, Setting the Limits for Genotoxic and Elemental Impurities

Request for ANDA Number and Labeler Code
Request for Facility Self-identification, DUNS Number, FEI Number
Generic Drug Data and Dossier Gap Analysis
Preparation of Assessment Report and Guidance for Remediation
Pre-assigned ANDA number request
Regulatory Assessment of Master Dossier against country-specific requirements for Generic Drug Registration, Compilation, Review & Submission
Compilation of modules as per the CTD and country-specific submission requirements
Technical review of the compiled CTD sections
Finalization and submission of complete dossier to agencies

Pre-submission Administrative Activities

Response to Queries

Regulatory assessment/gap analysis of the queries/information requests
Finalizing the strategy in the preparation of response to queries
Coordination with client for generation of data
Compilation, review of the response documents with scientific/logical inputs
Submission of the response document

Evaluation of Change Controls (for site transfers, manufacturing process changes, supplier changes, extension of retest period/expiry, change in batch size, container closure system changes, etc.)
Preparation and guidance for submission and Post-approval Submission Strategy
Guidance on Additional Documents/Data Generation/Requirement
Compilation, Review and Submission of Post-approval Changes Package (Supplements /Amendments/Variations)

Generics
Manufacturers

Development Stage

Pre-submission Administrative Activities

Response to Queries

Submissions for Post-Approval changes

Lifecycle Management Services

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