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Introduction to Generics

Global Regulatory affairs for the generics pharmaceutical industry has evolved over the past few decades and is experiencing an increasing demand from emerging, as well as key countries like the US, Europe, and Canada, given the lower prices offered by the generic drug manufacturers. However, there still exist a few untapped markets for the generics industry and therefore, different Regulatory authorities like the US FDA, Health Canada, and the EMA/MHRA are supporting the generic drug manufacturers to explore various opportunities related to generic drug dossier submission and generic drug registration to overcome the existing challenges during generic drug development.

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Centralizing Regulatory Services for Generics

Regulatory requirements for generic drug products differ from one country to another. Therefore, to stay compliant and updated with the regional and global Regulatory standards, it is essential to understand the Regulatory requirements for each country before submitting the MAA to the respective Health Authorities. Freyr’s global Regulatory team provides an in-depth understanding of local and regional generic drug dossier submission requirements across 120+ countries.

What are Your Challenges?

Explore how Freyr can assist you in different regions

End-to-end Regulatory Services

Freyr offers comprehensive global Regulatory affairs services starting from product development to lifecycle management and commercialization, to help companies maximize their asset value. Freyr’s global pool of Regulatory experts enable Life Sciences, Consumer Pharma, and Bio-Med companies to comprehend and manage the challenging and diverse Regulatory requirements to expand their business potential in the new and existing markets.

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What We Do

Freyr provides Regulatory solutions and services to large, mid & small global life sciences companies. Our highly skilled Regulatory experts understand customer requirements and customize the process for end-to-end drug approvals & Regulatory Chemistry and Manufacturing and Controls (CMC) support through optimum utilization of resources.

Freyr is a leading generics Regulatory service provider and has the experience and expertise to support our clients in different phases of generic drug registration, right from dossier compilation to lifecycle management. With an integrated drug delivery approach and efficient Regulatory roadmap strategy, we help our customers to stay 100% compliant with dynamic Regulatory requirements and thereby reduce the approval timelines.

Drug Approval Process in the EU and US

The development of innovator drug products involves a huge investment of money and time unlike generics, which are cost-effective and require less time to bring drug products to the market. The innovator drug manufacturers are required to submit the Investigational New Drug application (IND) in the USA, (IMPD application in Europe) and New drugs application in the USA (MAA in Europe) after the successful completion of clinical trials. Similarly, generics drug manufacturers are required to submit the Abbreviated New Drug Application (ANDA) in the USA and Marketing Authorization Application (MAA) in Europe post the completion of Bioequivalence studies.

Drug Approval Process in EU and US

Clinical Trails ~ 6 Years

  • Discovery Phase & PreClinical Studies 6 Years

  • Phase 1

  • Phase 2

  • Phase 3

  • Regulatory Review
    0.5 - 2 Years

  • PMS

  • Exclusivity

  • IND Submission to USFDA
    IMPD Submission in EU
  • NDA Submission to USFDA
    MAA Submission in EU
  • 12Years Market Exclusivity
    8+2+1 Market Exclusivity
  • Product Development
    ~10-12 Months

  • Biobatch Production
    and Stability data
    ~7-9 Months

  • Bioequivalence
    Studies
    ~4-6 Months

  • Regulatory Review
    8-10 Months

  • PMS

  • Exclusivity

  • ANDA Submission to USFDA
    MAA Submission in EU
  • 180 day Generic drug
    Exclusivity Provided by USFDA
    EU-No Exclusivity for Generics

Freyr Industry Leading Scale

150+

MAA

350+

DMFs

250+

ANDA Submissions

1500+

Annual Reports

4K+

Post-approval Activities

3K+

Renewals

11K+

Label Processed Annually

Latest Resources

  • Blogs

    Pharmaceutical Labels and Errors to Avoid

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  • White Papers

    Control of Nitrosamines in Drug Products Regulatory Considerations

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  • Past Webinars

    The Regulatory Pathway for Expedited Access to Malaysian Pharma Industry

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