Fixed-dose combination Products (FDCs) have become increasingly famous due to the safety, efficacy and Regulatory pathways they encounter while registering into newer markets. However, with the dynamic Regulatory requirements, registering FDCs often fails to comply with updated standards. With this whitepaper, a methodical approach to registering FDCs in a newer market has been lucidly explained. It also throws light on Regulatory hurdles faced by pharma companies. In conclusion, the artifact focuses on the steps for filing FDC products in a new market and the Regulatory hurdles one should be aware.
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