As consultants we are  entrusted  with proprietary and confidential information. We will  work with you to achieve your objectives. We will  respect the confidence entrusted to us. Our business is founded on strong ethical principles and quality.
Confidential documents from the client or from us will be treated as such. Emails and other correspondences are also treated as confidential documents.

We keep our clients informed. We deliver what we promise. We will work in your office or at our own offices depending on the agreement.

If you have a question relating to Pharmaceutical regulatory affairs contact us. We guarantee privacy and confidentiality. Our charges are by the hour or by project. Projects tend to cost less than by the hour. Contact us to discuss your best option.  You can get ongoing support through our discounted prepaid services by as much as 20% .

The following services are provided.

  • eCTD publishing and submissions
  • DIN applications
  • ANDS/S/NDSs/ANDA
  • IND/CTA
  • Investigators  Brochure
  • Product license applications(Traditional & non-traditional)
  • Site license applications
  • Medical devices applications
  • Product monographs
  • Clinical Overview and Summaries
  • Non-clinical overview and summaries
  • Chemistry manufacturing and controls

We also provide training course. The following courses are offered online. They provide an easy means to train your staff.

You can find more information online  or by writing to us

regulatory affairs meeting