Loading
Fervor Health Solutions

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)

Submissions for Post-Approval changes

Lifecycle Management Services

  • Due Date Tracking of Annual Reports/Renewals
  • Submission Strategy of the Annual report/Renewal
  • Compilation, Review and Submission of Annual reports and Renewals on scheduled time for Product Registrations across the globe
  • License Tracking & Management

Let's talk about your project

Get in touch

© 2021- 23. Fervor Health Solutions. All Rights Reserved.