Overview

As the Generics industry has evolved and matured, it is being encountered with intense scrutiny from the global Regulatory Agencies, and thus the need for specialized Generics Regulatory services has attained prime importance. It indeed helps to improve capabilities in bringing new, safe and cheaper Generics to markets.

Generic and Innovator drugs bear many similarities, except the pricing. A Generic drug has the same dosage, safety, effectiveness, strength, stability, quality and performance characteristics as the respective innovator drug. It is also consumed in a manner similar to an Innovator drug however, it is far more economical. With an objective to produce high-quality pharmaceutical formulations, Generics drug manufacturers strive to identify the most critical needs of patients across the globe by devoting their resources for developing safe, effective and affordable healthcare solutions as an option to Innovator drugs.

Innovators are protected by patents and exclusivities that influence how and when a generic drug can be approved and marketed. These patents, usually issued by the US Patent and Trademark Office, protect the Innovator drug manufacturers by prohibiting others from selling generic versions of the same drug. Duration of marketing exclusivity for Innovator drugs can also impact the approval of Generic drugs. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the Generic drug can receive full approval and can be distributed and made available to the public.

Generic drugs are more cost-effective when compared to Innovator counterparts because they do not have to repeat animal and clinical (human) studies that were required for the Innovator and only pharmaceutical equivalency needs to be proven, instead. In addition, multiple applications for Generic drugs for the same formula are often approved, which creates competition in the marketplace that typically results in lower prices.

To withstand the competition, Regulatory affairs play a central role in the various phases of Generic drug production: development, manufacturing, Generic drug registration, lifecycle management and Generics CMC. Fryer, a leading Generics Regulatory services provider, has the experience and expertise to handle the different phases of Generic drug registration, from development to dossier gap analysis, Generics CMC activities, preparation and submission to lifecycle management. Generics CMC activities provide strategic support to the manufacturers during development stage, guidance for the generation of data and strategy for registration on pathways. Freyr's proven Generics Regulatory services include:

  • Compilation, review and submission of about 40 ANDAs to multiple clients and have not received RTR for even one ANDA
  • End-to-end Regulatory support provided for generic manufacturers from development stage of the product to post-approval submissions and lifecycle management
  • About 100 MAAs to EU countries by MRP, DCP and National Procedures
  • Generics CMC activities like compilation/conversion (paper format to eCTD) and submission of about 100 DMFs to US FDA and Health Canada/EU
  • Every year, Freyr’s Generics Regulatory services support clients with Regulatory strategy, submission planning, compilation and submission of supplements/amendments/ variations for proposed major changes (about 100), moderate changes (about 300), and minor changes (about 800) to the approved ANDAs/MAAs/ANDSs/Dossiers
  • Every year, Freyr’s Generics Regulatory Services support clients with the submission of lifecycle management activities like Annual Reports (about 750) and Renewals (about 1000) with tracking, follow-up for additional documents, compilation and submission for already approved ANDAs/MAAs/ANDSs/Dossiers/DMFs/CEPs

Freyr Expertise

Development Stage

  • Prototype formula clearance for IIG (If required CC can be filed with FDA)
  • Quality by Design (QbD) protocol & report review
  • Final formula clearance w.r.t IIG, dose proportionality, size and shape
  • Support in finalization of API, Excipients and packing material specifications and test methods
  • 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 and Stability study
  • Guidance on setting the limits for genotoxic and elemental impurities

Pre-submission Administrative Activities

  • Request for ANDA Number and labeller code
  • Request for Facility self-identification, DUNS number, FEI number

Regulatory Assessment/Gap Analysis

  • Gap Analysis for source documents/data
  • Preparation of assessment report and guidance for remediation
  • Regulatory assessment of Master dossier against country-specific requirements for 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

Response to Queries

  • Regulatory assessment/gap analysis of the queries/information requests
  • Finalising 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

Submissions for Post-Approval changes

  • 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.) along with supporting documents
  • Preparation of post approval submission strategy
  • Guidance to client on submission strategy
  • Guidance on additional documents/data generation/requirement
  • Compilation, review and submission of post-approval changes package (Supplements/Amendments/Variations)

License Cycle Management Services

  • Tracking the due dates of Annual Reports/Renewals via tracker
  • Guidance to the client on the 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 (i.e., United States, Canada, Europe (EU), Australia, Asia Pacific (APAC), Africa, Commonwealth of Independent States (CIS), Middle East and North Africa (MENA), Latin America (LATAM) etc.)
  • License tracking & management