Have you applied for a new site licence and even though you had help, you failed to gain approval?

I've helped companies succeed in gaining approval for their new site licence even when they failed in their previous application. How can I achieve this when others fail? I work with you to make sure you understand the requirements, making sure you know what to expect and helping you implement the right systems for your business which meet the regulatory requirements.

In practice many consultants do a basic job, when you ask for support at the lowest possible price, which is all too common, you receive the lowest price service. For a new licence how much might it cost, I can do the basic work a generic off the shelf QMS lets say £10,000 a round number to make the calculations easy it takes 3 months to write and 3 months to apply and have a failed inspection then you pay £30,000 for another consultant (me) to do a high quality job with a QMS which is designed to meet your requirements and I support you in reviewing your site to make sure it is sutable and that the QMS is implemented and adapted for your business, this takes 6 months then another 3 months to apply and have a successful inpsection so after 15 months you now have the licence. You start trading making £10,000 profit per month.

Alternatively you come to me first, I help you write and implement a new QMS designed to meet your requriements and I support you setting up your site correctly in the first instance you pay £45,000, 3 months to write based on your business requirements no requirement to adapt. Then 3 months to apply and you are granted your licence 6 months after we start. You start trading making £10,000 profit per month.

Compare the 2

In the first case starting with the cheap approach you paid £10,000 with the £30,000 plus additional costs for adaptation and in 15 months made no profit, by 18 months you have made £30,000 equating to a £10,000 loss overall, with break even at 19 months.

In the second expensive approach you paid £45,000 and in 15 months you made £90,000, already a profit already of £45,000 with break even at 10.5 months after the start of the project. By 18 months you made another £30,000 and by the break eaven point for option 1 of 19 months you have made another £10,000 making a total profit of £130,000. So by choosing the initial cheap consultant you have lost £130,000 in profit.

This example is based on a real project with some changes so you can't identify the client; they went for the cheap option more than once so had even more delay and more cost and at both attempts they failed to gain approval for the site licence. I followed the process as above and they passed first time. Their revenue increased over time so the flat £10,000 profit per month is an underestimate of what we achieved but it makes the numbers easy for me to explain.

I hope with this real example you can see that having the best consultant support your company is in fact finacially better for you over time as you get what you need instead of a cheap alternative.

I have been asked for a cheap option using my own off the shelf SOP's it doesn't work, do the job right get make sure the Pharmaceutical Quality System you spend time implementing is right for you and you will benefit much more than going for a discounted alternative. I offer value not discounts.