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US PRE-IND MEETING ASSISTANCE
Donawa Lifescience Consulting (DLC) has over 20 years’ experience of contact with FDA, either through informal means, such as telephone and e-mail, or through formal written communications and meetings.
For a pharmaceutical manufacturer developing a new drug intended for sale in the US, one of the milestones of the development plan is the pre-IND meeting with FDA, during which FDA reviews and comments on the company’s draft clinical trial protocol and associated documentation.
Effective preparation for the pre-IND meeting is essential if the company is going to leave the meeting with positive results. DLC can help in preparation for the meeting, and if requested, attend the meeting either on behalf of the company or as support to the client’s own personnel.
Following the pre-IND meeting, DLC specialists can help with development of the IND submission, whether this is for Phase 1, 2 or 3 trials.
In addition, it may be beneficial to have further meetings with FDA prior to submission of NDA or BLA applications, and DLC is also able assist companies in preparation for and attendance at these meetings.
Please contact us to see how we may be able to help.
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