Selecting
a Toxicology Consultant Firm
Not
all toxicology consulting firms are equally scientifically qualified
or have comparable practical experience in drug development. We have
a solid reputation for successful, timely, cost-effective outcomes
for clients. Furthermore, we willingly deal with the nuts-and-bolts
of drug development – not just provide overviews of problems.
We
work equally successfully with virtual and near-virtual firms, with
mid-size firms that may have their own toxicologists, and with “Big
Pharma”.
We
are small enough to focus on each client’s specific needs. At the
same time, we have the flexibility of adding expert, experienced
staff to an assignment to meet a challenging deadline on a larger
project, such as preparation of an NDA submission.
We
are focused on efficient drug development, not on academic exercises
or “nice to know” studies.
We
have no arrangements with any CRO’s and do not accept commissions
from them.
We
can work with any MAC- or PC-based special software of clients.
Whenever
possible, we use information from study reports or pre-existing
drafts instead of creating documents wholly from scratch, to save the
client money.
We
are skilled at noting deficiencies and inconsistencies in study
reports, so that problematic findings or interpretations can be
addressed before the regulatory submission is finalized.
We
generate submissions that are ICH compliant and acceptable to both
FDA and the EU.
We
do not use staff who are marginally skilled or who lack suitable
experience.
We
are experienced at creating seamless NDA nonclinical submissions that
contain studies and drug development strategies from several
different firms.