07711 781764   dave@paradigmshiftconsulting.co.uk

Paradigm Shift Consulting Ltd are a boutique consultancy, focussing on services around Good Distribution Practice and Wholesale activities, specialising in GDP Training, QMS and SOP review/writing, temperature mapping, validation and more. We also work in Private Healthcare, setting up Travel Clinics, Patient Group Directions and Online Doctors. Our tried and trusted team of professionals can help you to add value, reduce overhead, bring new revenue streams or review and finesse operational process. Our associates support in the following areas:

Contract Responsible Person (RP) or Deputy Contract RP support

We have a team of Contract RPs, Contract Deputy RPs and regulatory consultants who can offer phone and email support, and site visits, at a frequency that suits you and your business, subject to mutually agreeable terms and interview. Whether you need a little support and advice, or complete support, we can help. Where possible we prefer to work with existing RPs and offer them regular support and training, keeping the skill within your business.

Good Distribution Practice Training

We can provide training for all levels of staff, and for any GDP related activities. According to the EU Guidelines on GDP -all- staff should be trained in GDP before carrying out their duties, and RPs must take regular update training. Whether you join one of our external sessions, or we come to you, we have a solution to suit every pocket and every business model.

Under Investigation or Suspension?

Being suspended by the regulator can be stressful and leave you with permanent damage to the reputation of your business. Paradigm Shift Consulting have assisted a number of suspended WDA holders in their return to full GDP compliance. Subject to interview and explanation, we can help you be reinstated, and help you deal with the MHRA and their IAG in any subsequent corrective or remedial actions. Each inspector visit costs you £1936 for one inspector for one day. Can you afford NOT to contact us? Please note we don’t work with everyone, and if you are not fully committed to patient safety and full GDP compliance we aren’t the company for you.

Good Distribution Practice audits

We can visit your site and conduct a third party audit of your site, following MHRA inspection protocols, help spot any gaps in compliance and assist in plugging them. Whether you need a GDP Gap Analysis vs 2013/C 343/01, a 3PL (Third Party Logistics) GDP audit for an existing or prospective site, or an operations review, we can help.

GDP SOP Audit

Standard Operating Procedures are the backbone of your Quality Management System. We can assist you in streamlining, rewording, or completely reworking your SOPs. Or check them to ensure that they are as good as you think they are. Are you compliant with 2013/C 343/01? Not sure? Ask us.

Pharmacist and Nurse-led PGDs

We can assist you in deciding which Patient Group Directions may fit your business, and help set up clinics for Erectile Dysfunction, Hairloss, and more.

Online Doctor and Travel Health, including vaccination PGDs

As a third party provider for the PharmaDoctor Travel Clinics, we can help you decide if setting up a private travel health solution is a viable model for your business. We also have the expertise to write bespoke PGDs, or to assist with an online doctor platform. From marketing concepts to launch, we are here.

Wholesale Dealer Licence?

We can help you gain your Wholesale Distribution Authorisation aka WDA(H) from application through to inspection, providing all the expertise you need to set up your wholesale operation.

Cost Reduction

Our Energy Consultants and Cost Reduction experts work on a “no win, no fee” basis. If we are successful in winning a tender we are paid via commission from the winning energy supply company. And if you don’t like the deal, you don’t sign up. A definite win-win opportunity.

Free 5 Minute Consult

Do you really need our help? Might we be able to signpost you somewhere free of charge? Quite possibly. We offer you a free five minute consultation to see if you genuinely need a consultancy quote… or if we can help you for free. Contact Us

Why us?

Paradigm could help you achieve new, profitable ways of working and thinking and set up supply deals and links with like minded people. Our focus is on training you and your team into consistent compliance, and helping them maintain and develop their business. Many companies offer support, but it is often a “one size fits all” which can mean lots of value or very little value. Our offerings are bespoke, and therefore often more financially viable, as we do not consider a pharmacy “skimming” wholesaler the same as a short liner, virtual wholesaler or large scale exporter. Please email us in the first instance and we will usually revert within 24 hours, subject to availability. We are of the opinion that business doesn’t have to be difficult or unethical, and that relationships should be built to last as well as generate the most benefit with the least pain. Welcome to a new paradigm!

Pharmacy Support

Paradigm Shift Consulting primarily consults and supports customers in relation to Good Distribution Practice, Wholesale, Travel Clinics,PGDs and Cost reduction, but we are also focused on independent pharmacy. Whether you need sensible and concise SOPs for your internet pharmacy, advice on automation, or a dummy GPhC Inspection, we can assist.

Good Distribution Practice

We are GDP focussed, offering audits, SOPs, QMS, training and commercial advice. Need to train drivers and warehouse staff on a budget? We can help you. Advanced training for RPs or senior team members? Our bread and butter. Need a bespoke course based around your own specific business model, we’re here to help.

Private Healthcare

As third party resellers of the PharmaDoctor suite of products and services, we are well aware of the decreasing revenues from NHS prescriptions. With a further slashing of your practice payments, is now the right time to do something different?

Wholesale Solutions

Whether you want to set up a pharmacy “skimming” site, or a full blow export warehouse, we can help from concept through to launch of your business. Please note that although we offer advice and support, we are not a sales agency and do not prospect for you.

All licence holders start equal… a good regulatory consultant is what can make the difference.About Us!

Dave Rushton

Dave Rushton is founder of Paradigm Shift Consulting Limited. With a career spanning over 13 ...