STRONG FOUNDATIONS – 2025

“Strong foundations allows for greater heights to be reached…”

One thing after another…

The pandemic years were difficult and fraught; the first of its kind sweeping the UK on a scale not seen since 1918. This led to all kinds of difficulties and challenges across the political and social spectrums, the commercial and business sector and in particular, our treasured National Health Service. And it is still reverberating in our society.

Since then, we have had a change of government in the UK, and with it, a change in Health Secretary,  Wes Streeting.  There has been an increased focus on the 10-year plan for the NHS to shift care from hospitals to the community, establish new neighbourhood health centres, and digitise services. Key changes include merging NHS England with the Department of Health and Social Care.

And now crises has emerged in Europe and further afield which is are a challenge on many fronts, not least in medical and patient care. The repercussions may be felt for quite a long time…

Staying Power

Paradigm Shift Consulting Limited has been a stable presence throughout, establishing strong foundations while modifying our services and support functions onto the web in order to accommodate the restrictions, and (where possible) the budgets of the clients seeking our assistance. We weathered this storm and have supported many others along the way, only because of the strong foundations we have established.

Our online training and  support continues in the aftermath of the Covid-19 pandemic as many organisations have adopted hybrid working as an ongoing practice for their staff.

Brexit and Covid-19 have caused significant issues across the market with the UK now being a third country and EU countries becoming “listed” countries to us. The role of the Responisble Person (import) was introduced in the UK as a result of Brexit, specifically to ensure compliance for the importation of medicinal products from the European Economic Area (EEA) into the UK after it ceased to be an EU member state.
This role became necessary because the UK no longer had direct access to the EU’s regulatory framework, requiring a new system to verify the safety and quality of imported medicines, and was formally established in guidance issued by the MHRA following the UK’s exit from the EU.

 In addition, the Windsor Framework has now been implemented. These new arrangements allow for the smooth flow of trade within the UK internal market and are underpinned by data-sharing and technology. This framework will ensure that there is real-time data on goods movements to support risk analysis, removing the need for the extensive bureaucracy and checks that will continue to apply for goods moving on into the EU.

The Human Medicines Regulations (2012) has been amended to accommodate this, particularly in the area of import/export.

Strong Foundations means strong roots

Having strong foundations has enabled Paradigm Shift to come through the recent difficulties with continued strength and confidence.
We have won awards (most notably Family Business of the Year) and other plaudits, made new friends, and taken on new associates and clients. Subsequently we have an ever-increasing collection of references kindly sent to us from clientele who have benefitted (and continue to do so) from our services, support and free consultations and licence acquisitions or terminations.

Below are some choice extracts from the many letters of thanks we have received (some with chocolate and gifts!) Some are very recent, some less so. Collectively, they represent the strong foundations of what we have established so far, upon which we can be confident about our future, and the future of our clients. That confidence we endeavour to instil  into our services, because we want everyone else to share the confidence and benefit from strong foundations.

Testimonials from Clients

“Mr. Rushton and his company are and always will be our first point of contact. I can trust him to give us accurate information and advice when it comes to regulations and procedures”.
~Tech Advisor~

“A well organised, structured training programme that suits all experience levels…
The content is precise and gives you a clear understanding of each chapter of the guidance. I would highly recommend their GDP Training…”
~ J.K.~

“…compliant, pragmatic advice that allowed our business to develop safely and in line with regulations, which are explained in an accomplished yet easy-to-understand way, allowing a client to grasp the detail easily. We are happy to recommend Mr. Rushton and his team to other colleagues and organisations”.
~Supply Service~

A final word from the Founder and CEO
of Paradigm Shift Consulting Ltd., Dave Rushton…

“We started out as and continue to aim to be, a service to our friends in the pharmaceutical industry, ultimately helping patients access quality medications and reducing the burden on the regulator. There are so many challenges that we all face, without business being made more difficult or cost prohibitive.

This is why we are still the only company to openly offer free advice, free licence terminations and free initial review and support with IAG and CMT remediation cases. We recognise how stressful it can be to have poor regulatory outcome, and we will always offer you what is right for you and not what will profit us.

“We frequently recommend that people do not try to obtain a licence, especially if they have no experience or customers, and we will often quote lower fees because we recommend cost-effective, common sense solutions.

A recent example being a proposed business where a Doctor, Pharmacist and Dispensing Technician requested a quotation for a QMS and RP for an export business to “5 or 6 African countries”. On review I noted that 80% of their products are on the list of products banned for trade, unless manufactured for export. (Click here to see the MHRA page on this subject).

I informed them that they did not have a business model that would succeed and that anyone quoting them was only interested in their money… and they replied how grateful they were as the other two consultancies had already quoted them costs.

“I am often told that it is not my place to tell people if their business will sink or float, and that we should “just take the money”.
This never sat right with me, because in an environment where patient safety and product quality are our ultimate goal, we need to work with certainties. We avoid grey areas (unlike many companies who will look to exploit them for financial gain) retaining our integrity at everyone else’s cost. We do not “hope for the best” or “help” people into financial ruin and risk to patients.

We remain committed to our clients, our team and, of course, the patient.

Any suppliers wishing to sign up are welcome, and any discounts or “kick-backs” will go to the client, making simple and effective solutions available at realistic prices.

I wish you health and happiness!”

Dave