Introduction to Generics
Global Regulatory affairs for 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. But still, there exists 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 and overcome the existing challenges during generic drug development.Know More
Drug Approval Process in 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.
Clinical Trails ~ 6 Years
Discovery Phase & PreClinical Studies 6 Years
0.5 - 2 Years
- IND Submission to USFDA
IMPD Submission in EU
- NDA Submission to USFDA
MAA Submission in EU
- 12Years Market Exclusivity
8+2+1 Market Exclusivity
and Stability data
- ANDA Submission to USFDA
MAA Submission in EU
- 180 day Generic drug
Exclusivity Provided by USFDA
EU-No Exclusivity for Generics
Centralizing Regulatory Services for Generics
Regulatory requirements for generic drug products differ from country to country. 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 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?
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End-to-end Regulatory Services
Freyr offers comprehensive global Regulatory affairs services starting from product development to lifecycle management to commercialization, in order 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, in order to expand their business potential in the new and existing markets.Know More
What We Do
Freyr provides Regulatory solutions and services to Large, Mid & Small global Life sciences companies across the globe. Our highly skilled Regulatory experts understand customer requirements and customize the process for end-to-end drug approvals & Regulatory Chemistry, Manufacturing and Controls (CMC) Support through optimum utilization of resources.
Fryer 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 road map strategy, we help our customers to stay 100% compliant with dynamic Regulatory requirements and thereby reduce the approval timelines.