For many pharmaceutical and biotech companies, the submission of a marketing application – such as a New Drug Application (NDA), Biologics License Application (BLA) and Marketing Authorization Application (MAA) – is a huge milestone in the regulatory process, eclipsed only by a positive review result – approval or licensure.

Whether you are a small or mid-sized pharmaceutical or biotech company that will soon be approaching its first NDA, BLA or MAA, or you’re looking for a smoother submission process for your latest application, establishing efficient processes and setting clear expectations can help accelerate successful regulatory and commercial outcomes.

An efficient approach, with minimum decision reversals, conflicts, rework and surprises can yield the best possible outcome. An outcome where a timely application that demonstrates quality, consistency and strength of message results in a positive first-cycle review decision and a label that favorably represents the product in the context of the standard of care and of already-launched competitive medicines.

Having supported hundreds of marketing applications in just the past 5 years, Cardinal Health Regulatory Sciences shares the imperatives that have had the most significant impact on marketing application success, in terms of completeness, quality, timeliness and maximum probability for a first cycle review result.

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