Specialist
knowledge

We provide clients with very focused modules of assistance using our specialist knowledge and wide experience in the GDP area.

Do I need this?

Well-resourced pharmaceutical companies can usually handle most of GDP themselves, but occasionally need some outside assistance on a specific specialist topic that they have not covered before.

Sometimes an independent view on something, often through conducting an audit, can be valuable.

Related services.

There are a wide range of specialist areas across all aspects of GDP that HTF can assist clients with, here are a few examples.

GxP Auditing

Our quality team all have experience in a range of auditing, focused on GDP but also some GMP audit skills. We can conduct a one-off, or regular audits of a variety of situations, from in-house or contract storage sites, to administration sites (QMS only), transport providers and other 3rd parties that you may use.

Training

We can develop and provide bespoke training to suit your requirements, covering all aspects of GDP and its compliance related roles and responsibilities. We provide one-to-one support packages for new and prospective RPs, with a mentor available, as well as structured training sessions over an agreed period.

UK Post-Brexit

As a team we have guided many clients through the evolution of the regulatory authorities’ restructure after Brexit. The new role of the RPi in the UK is one concrete example, as well as assisting UK WDA (H) licence holders who, post Brexit, were no longer able to store medicines in the EU, or sell medicines to end customers in the EU.

Inspection Preparation

Whether you are about to undergo your initial inspection or are subject to a routine inspection, we can assist, give support and prepare you in being ready for your inspection. This could be a quick review on specific areas or a full GxP audit.  We are able to develop an offering that suits you. For some clients, a full GxP audit is required as a rehearsal for the real thing, for others a more simplified but focused review on key areas works best; whatever the request, we can work with you to ensure that you are inspection ready.

Authority Liaison
Regulatory Authority Liaison

HTF has a good relationship with regulatory authorities and is often in contact with various organisational contacts, on behalf of clients, for clarification on regulatory guidance as well as for advice on client specific matters.

Northern Ireland

Post-Brexit, the evolution of Northern Ireland and its connection with the rest of the UK & EU has seen regular updates and changes. The Northern Ireland protocol was replaced by The Windsor Framework; HTF regularly advise clients on how to handle matters related to medicinal products and their relationship to the UK Supply Chain

Decoration

Get in
touch

If you need more detailed information on any of these related services, or advice on which services you do need, please get in touch.

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How we can help.

Whether you need some support for your existing quality team or need HTF to manage the whole of a new licence project, we can provide the expertise and collaborative approach that will result in an on-time and successful project.

Often our project team then continue as key contract resources in the operational aspects that follow.

A process that starts at any point.

No two clients or products are the same and everything we do for a client is bespoke, making use of the wide variety of our team’s previous experiences.

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From an initial meeting, we can often understand in broad terms what is needed and what part we can provide. There is no cost or obligation to use HTF at this stage.

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We help obtain or update a licence

We can manage the project from application through the inspection(s) to the award of the licence(s).

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You have your own team at HTF

Each client has one or more regular HTF personnel working with them, creating a close working relationship. In addition, the knowledge base of the whole team is always available to every client.

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Adapt and evolve our service

As a client’s resources, product portfolio and general situation change, we can adapt our services to suit, providing increased or decreased services as required by you.

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Longstanding relationship built

We often partner with our clients for many years, flexing our services as their situation changes.

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We make any amendments

Licences are regularly varied and expanded, we can manage these as smaller projects.

Case study.

We never divulge confidential details of any client publicly, but here is an anonymised example of some specialist knowledge we have provided recently.

Specialist knowledge: supply into Italian hospitals

An HTF client was planning to supply an EU licensed medicine to Italian hospitals

They were trying to evaluate whether it was possible to supply from EU entity direct, whether an Italian WDA is required, whether storage in Italy is required, etc. Through recent experience and local contacts HTF was able to guide them through the options and the pros/cons of each, helping them develop a strategy that best suited their product and company requirements.

What did we do?

Understand client objectives

Explain options available

Offer detailed local advice

Recommend local partners

Let’s talk.

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expert right now!

We are available Monday - Friday 09:00-17:00

+44 (0) 1527 572060

enquiry@htfassociates.co.uk

Have you found what you need? If not, we can still help.

Connect with HTF Associates for expert pharmaceutical solutions and client-focused guidance. Explore tailored services in Good Distribution Practice (GDP) and discover why we are your flexible global partner.

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