Registered Office: Paradigm Shift Consulting Ltd,The Old Mill, 9 Soar Lane,Leicester, LE3 5DE, United Kingdom

0330 133 0920

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Paradigm Shift Consulting Logo

0330 133 0920

Paradigm Shift Consulting Logo

Competent and Confident

 

We know how to help.
With over 634 years combined experience in Good Distribution Practice,
Pharmacy and Training, our team of consultants and associates can
help start, develop or remediate your operations.

The Right Way…

…to gain and maintain compliance.
Paradigm Shift Consulting focus on workable, common sense
solutions that satisfy both regulatory and commercial need.

Quality Management Systems

We can help review, remediate, update or create a fresh QMS, tailored to your specific needs.
Whether you operate or wish to set up a collection point model, wholesaler or a medicinal cannabis operation, we can help.

WELCOME TO PARADIGM SHIFT CONSULTING

Paradigm Shift Consulting Ltd is an ISO 9001:2015 certified consultancy providing training and quality management services to the pharmaceutical industry. Our core strengths are Good Distribution Practice and Wholesaling activities, specialising in Good Distribution Practice Training, Quality Management Systems (QMS), Standard Operating Procedures (SOP) review/writing, temperature mapping, validation and more.

Our tried and trusted team of professionals can help you to add remediate your failing site, add value, reduce overheads, bring new revenue streams or review and finesse operational process. Our associates support in the following areas:

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Contract RPs
GDP Training
MHRA Suspensions
GDP Audits
SOPs
WDA Applications
Compliance Monitor
Compliance Support
Free Consultations
Why us?
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Contract Responsible Person (RP) or RP's Deputy support

At Paradigm Shift Consuting our team of consultants can support you as named Responsible Person (RP) on your licence or as a Contracted Deputy to support your in-house RP. Furthermore, our team can offer phone and email support as well as site visits at a frequency that suits you, your business and your risk profile, subject to mutually agreeable terms and interview.

Whether you need a little support and advice, or complete support, we can help. Wherever possible we prefer to work with existing RPs and offer them regular support and training, keeping the skill within your business and keeping costs down.

Good Distribution Practice Training

We can provide training for all levels of staff, both in a face to face enviroment and an online capacity with our GDP Training online courses. According to the EU Guidelines on GDP -all- staff should be trained and deemed competent in Good Distribution Practice before carrying out their duties, and RPs must take regular update training.

Whether you join one of our external sessions, we come to you or deliver via webinar, 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 £2662 for one inspector for one day. Can you afford NOT to contact us? Please note we can’t work with everyone, and if you are not committed to patient safety and full GDP compliance we aren’t the company for you.

Good Distribution Practice audits

We can visit and conduct a third party audit of your site or your nomiated 3PL, following MHRA inspection protocols, raise deficiencies and assist with advice on remediating 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. We can also carry out remote audits as per the MHRA's current pandemic protocol.

GDP SOP Audit

Standard Operating Procedures are the backbone of your Quality Management System. We can assist you in reviewing, streamlining, rewording, or completely replacing your SOPs with Good Distribution Practice compliant documents, forms, logs and work instructions. Are you compliant with 2013/C 343/01? Not sure? Ask us for a free five minute consult and document review.

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.

Compliance Monitor

Paradigm can provide approved Compliance Monitors and are involved in the MHRA's pilot compliance monitor programme for GMP and GDP remediation supervision activities. As one of the initial companies requested to sit in on the meetings to discuss the pilot scheme, Paradigm Shift are the leading consultancy for full-service remediation, providing auditing, training, Contracted responsible persons and QA specialists, to prevent licence suspension.

Compliance Support Membership

As a member of the Paradigm Compliance Support Membership, you can enjoy reduced stress, on-site visits, email and phone support to help with any difficult scenarios, planned or unplanned deviations, change controls, Corrective and Preventive actions, GDP training (face-to-face or online) and document review/update.

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 can help you with your pharmacy woes. Whether you need to apply for an NHS contract, carry out a mock GPhC inspection, apply for a distance selling or internet pharmacy, Yes. Assist with gaining a WDA to buy and sell medicines? Absolutely. 

Medicinal Cannabis - CBPM

We can help you obtain the relevant licences to buy, sell, store and distribute medicincal cannabis, through us or our sister company Canna Strategy. You will need a WDA, Home Office licence and MS (Manufacturer Specials) to buy and import medicinal cannabis, and a suitable quality system and personnel.

Purchasing Solutions

Our professional and experienced buyers and consultants can work with you as an extension of your purchasing team, working directly for your company under a technical agreement and non-disclosure agreement.

Good Distribution Practice

We are Good Distribution Practice focused, offering audits, SOPs, QMS, training, Contracted RPs and Deputies and commercial advice. We can help you with training drivers and warehouse staff on a budget, Cogent Assured GDP training for RPs and senior team members.

Wholesale Solutions

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

Online GDP Training

Paradigm Shift Consulting can deliver training online via www.gdptraining.co.uk for Licence Holders, Managers, RPs and general staff involved in Good Distribution Practice activities, including Accounts, sales and operations personnel.

AL Medicines Ltd

Ishrat Mehboob

David has struck me as a very honest, hardworking and incredibly professional person. He is an absolutely critical member of the team whose knowledge and clarity makes it a pleasure to work with him.

I find him a joy to work with because he is totally reliable – he will always do what is expected of him and almost always exceeds all expectations.

Automated Data Management

Tony Palmer

I have no hesitation in recommending him to any of our clients, with direct contact between Dave and client as I have complete trust in him regarding his honesty, industry knowledge, and business ethic.

Chemi-Call Ltd

Dr Puja Shah

Paradigm was recommended to us as being one of the best in the field and I had the opportunity to work closely with them over several weeks to get us back into shape. They quickly identified the areas that needed improvement and prioritised each task.

Tanner Pharma Ltd

Jonathan Bracey

I have been very pleased with all the work Dave has delivered for us and have happily recommended him to other colleagues/organisations too.

Animalcare

Dave worked with us and liaised in communicating with the regulatory authorities to gain a succesful outcome within a week of our contacting Paradigm Shift Consulting.

Our experience of working with Dave and his team at Paradigm Shift Consulting has been very positive and I would highly recommend them when looking to solve licensing problems.

 

Rachel Smithson, General Manager UK

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Health Supplies Ltd

Brijesh Chachapura

Dave Rushton is appointed by Health Supplies Limited as a MHRA-GDP Consultant since September 2013 till date. Dave is responsible for the Quality Management System of MHRA Licence for the company

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Matrix Primary Healthcare Ltd

Akwal Singh

We first started working with Paradigm in 2014 when they consulted us in regards to an MHRA inspection.  We have found them to be a thoroughly professional and completely dedicated.

Veterinary Instrumentation

Andrew Taylor

Having spent the last 30 years in quality system management but with no knowledge or past experience of GDP, Paradigm demystified the whole of the EU and MHRA guidelines which allowed me to cross relate it to ISO 9001 and ISO 13485.

Whitworth Chemists Ltd

Jay Badenhorst

We have used Paradigm twice for training and consultancy in our Company, contributing to our compliance with GDP on our WHA(H). On many occasions we have had informal discussions about requirements, often influencing our ways of working and complying with GDP requirements.

Intercare

Paradigm Shift Consulting have been true and generous supporters of our
registered charity Inter Care Ltd.

Not only have they sourced a volunteer RP to assist us with our MHRA licence, but they have also donated GDP awareness
training to several members of the workforce to assist with our knowledge
and learning.

We thank them wholeheartedly for this invaluable support.

Diane Hardy
General Manager – Inter Care Ltd

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Remote Medical International

There have been numerous occasions where I have contacted Dave and his team out of hours for advice and last-minute meetings as our head office are based in the US.

Each time Dave and his team have joined no questions asked and are always willing to provide us with a service above and
beyond that expected in the interest of improving the sector as whole.

I can highly recommend Dave and his team at Paradigm Shift Consulting, and would only look to recommend them moving forward to anyone beginning their GDP and compliance journey.

Emma Pink
Responsible Person

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Jonty Kaulder

Dave has a well organised, structured training programme that suits all experience levels from beginner to expert level. The content is precise and gives you a clear understanding of each chapter within the guidance. I would highly recommend his GDP training which is available face to face and online.

Since progressing in my career Dave still offers continued support. I have always found working with him to be a friendly and professional service.

Jonty Kaulder,

Quality Manager and RP

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Grace Hards

Dave and the team are always happy to help us and advise us with any problems or queries that may occur, no matter how big or small they may seem and never lets us feel as though the question we are asking is “stupid.”

Thanks to Dave and his team at Paradigm, my confidence in this industry has grown immensely and I would aways recommends his courses and services to those who are starting out in the industry, but also as an updating knowledge base.

Grace Hards, RPs Deputy

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Malaria Consortium

Both Dave Rushton and Wayne Allen are dedicated and knowledgeable professionals, and provided the right level of assistance for our WDA(H) application.

They were always on hand to answer all questions and offered compliance and real world practical advice that helped us obtain our licence and improved our understanding of GDP.

We are happy to recommend Paradigm Shift Consulting.

Andrew Parkes
Matthieu Baudry

Responsible Persons

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Taurus Healthcare

We found ourselves in an unexpected situation requiring MHRA and Home Office licences to operation services within 14 days. Dave quickly stepped in with expert and professional advice and supported us through unchartered territory and expedited licensing arrangement to enable the continuation of services to patients resolving our predicament.

Dave continued to provide professional support and guidance through a transition period of site relocation and inspections until we were confidently operating business as usual.

Nikki Marriott
Director of Nursing and Quality

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