THE REGULATORY PROCESS
Submission, Review & Approval Strategy
Navigating through today’s complex regulatory environment requires skill and experience that Zymo can provide. We have worked successfully with multiple FDA divisions at every stage of product development from pre-IND submissions to NDA/BLA filings.
As part of your drug development team, Zymo Consulting Group can prepare everyone for regulatory meetings, attend these meetings, and make sure the action items are completed afterward..
Interface with Regulatory Agencies
Zymo Consulting Group provides direct interaction with myriad regulatory authorities to discuss preferred strategies, define submission needs, and negotiate with agencies to optimize drug development programs.
We have participated in and/or spearheaded pre-IND meetings, End of Phase II meetings, Pre-NDA/BLA meetings, and Type A & C FDA meetings.
Regulatory Submission Content Preparation
From the clinical portions of pre-IND meetings to clinical study reports, to integrated summaries of safety and efficacy, to the development of risk-benefit plans for an NDA/BLA/MAA, Zymo has the hands-on experience to build and write your documents clearly, concisely and comprehensively to meet national and international regulatory requirements.
We can also prepare the clinical sections of your annual reports, PSURs and DSURs, and assure that patient narratives for SAE reports are easily understood by any reader.