FAQ

/FAQ
FAQ2019-05-10T11:14:27-04:00
How do we get started?2019-04-30T10:03:54-04:00

As everyone knows, we start with a Non-disclosure agreement and we prefer that those agreements are 2 way, however.   We can use our standard agreement or a specific agreement to your company.

What is your technical or regulatory strength?2019-04-30T10:04:15-04:00

We have filed many INDs from paper to eCTD.  We enjoy solving early development issues and managing risk while maintaining patient safety and optimal data acquisition.

What are your weaknesses ?2019-04-30T10:04:31-04:00

We do not enjoy the ANDA process.  We feel that this has become more of a legal landscape rather than a science-driven process.

Do you have secure email?2019-04-30T10:04:53-04:00

Yes, we do.  We have a hosted MS Exchange server off-site and on-site. We typically use the off-site server and will provide you with those addresses once our collaboration begins.

How are documents shared?2019-04-30T10:05:06-04:00

We prefer that for confidential information that you “post” your documents to our servers or a hosted server certified by us.  In this way, we can control their distribution.  Once we download them, they only reside on our computers.

What is the best way to contact you?2019-04-30T10:05:19-04:00

Email is the best way to contact us as we are mobile and in constant contact with our office.   We will provide those instructions to you.

Do you work with start-up companies?2019-04-30T10:05:31-04:00

Yes, we do.  And we like to work with start-up companies.  But we like to work in a fairly structured way when necessary so that we know that we are adding value to your company and or product.

Do you work with non US companies?2019-04-30T10:05:50-04:00

Yes, we do and we like it.  Our experience has been extensive with our friends in Europe and Asia.

Do you work for investment companies or groups?2019-04-30T10:06:17-04:00

Yes, we do.  We can and have provided the following: Risk Assessment and Regulatory Success Probability & Due Diligence for Product or Company Acquisition