Not every consultant / client should work together. That is understandable.

I only take on new clients when I know that I can deliver real benefit / value. Otherwise, we are both wasting our time.

I try to avoid a potential engagement where there may be a mismatch between my skill set and client goals.

It is best to be honest about where the consultant strengths lie, whether the client is ready to work with a consultant, and how the client will benefit from the relationship.

Here is a list of situations where I believe we could likely to run into issues. If anything mentioned below gives you a concern, then perhaps we are not quite ready to work together.

I am NOT a good fit for you if:

1. You are satisfied with a flavor of the month approach, focused on business as usual, and are not willing to try new things, take risks, or experiment with a different approach, if the project otherwise meets regulatory requirements, and the steps and reasoning are clearly explained and documented on a project chart.

2. You prefer your own approach even when it is proven to not fully agree with those of regulatory agencies such as the US FDA.

3. You are hiring a consultant to merely justify an anticipated and unpopular re-engineering / reduction in force action.

4. You are looking for the lowest cost provider, not the best.

5. You are not willing to roll up your and the team sleeves and put hard work into your project to achieve the mutually agreed-upon results.

6. You are not invested in your company success, whether you are the CEO or not.

7. You are looking for a one time, quick fix, rather than a continuing process that improves your company condition when you fully commit to it and the longer you work on it.

8. You do not have additional funds, resources / personnel to invest in the compliance project.

9. You are not willing to allocate a budget for the needed compliance project, and prepay about 1/3 of the agreed upon consulting fee prior to its start.

10. You do not deal well with constructive criticism from an outside peer.

11. You are looking to reduce your regulatory budget by getting free advice.

12. You are not interested in achieving full compliance with regulatory requirements with the project.

13. You view regulatory compliance issues as bureaucratic intrusions rather than business tools to ultimately reduce patient / user risks with your product.

14. You are not comfortable in monitoring a project from a mutually agreed to written Gantt Chart Project Plan, with stated Milestones, Tasks, Estimated Dates, and Deliverables.

15. You require an in-person / face time / on-site presence to fulfill a consulting project.

But, based on the above ...

If you feel we could be a good fit for your project, just contact me, preferably by e-mail, for a no obligation discussion to see if we are a match.

J. E. Lincoln and Associates LLC

Medical Devices / Pharmaceuticals / Quality Systems / Regulatory Affairs Consultants

 Phone 435-840-0252  /  E-mail jel@jelincoln.com  /  www.jelincoln.com

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