Regulatory Consulting

When does it make sense to hire a regulatory consultant?

Here a few reasons our clients have given us:

  • During the planning and startup phase of a new company.
  • When you need an outside perspective or expert advice.
  • When your FDA compliance program has slipped up.
  • When hiring a regulatory affairs manager is not in the budget.
  • When you're dealing with a new regulatory challenge.

There are times when hiring a consultant will save you time and money. Typically these times are more clearly seen in hindsight.

We can lay out an overall roadmap for all your regulatory compliance efforts, assuring that every aspect of your FDA compliance status is addressed in a logical sequence.

We offer an affordable coaching program that will provide ongoing mentoring for your staff as they develop and implement your GMP Program.

We can also take the heat off you and your staff during occasional periods of excess technical work, or help reduce the anxiety of a product recall or other compliance crisis.

Some companies prefer to delegate all their FDA liaison and communications work to us.

So in a consulting role, there are a number of valuable services we can provide. If you'd like to discuss it further, please give us a call.