Jane Allen Consulting, Inc.

  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.