Pharma Integrity

Services

Pharma Integrity works with pharmaceutical companies, and agencies working with pharmaceutical companies, to understand and apply Code and legislative requirements in the UK & Ireland.

To enquire about any of our services listed below, contact Info@PharmaIntegrity.com 

 

Bespoke company training courses are available upon request.

Services

What Our Clients Say

‘As ever, Caroline provided an excellent personalised training programme for our business.  Her knowledge of the Code of Practice is exceptional, and she was able to give real world examples to ensure the team could apply this in practice. Caroline also went the extra mile in providing follow up support and tailoring the session using face to face and online delivery. I would strongly recommend Pharma Integrity as your first choice for Code related support and we will certainly be using their services again.’ 

Founder and Director, ALTURiX

Services

Creation of bespoke company policies and procedures​

Whether you are a new start-up company establishing operations in the UK or Ireland, or you are an established company looking to revisit your in-house policies and procedures, Pharma Integrity can offer you insight and produce written documents to suit your needs now and for the future.  Pharma Integrity ensures all documents are written so that they cover all the external and internal requirements required, but are easily understandable for users, so they truly fulfil their function.

Services

Copy approval & signatory services (Medical & non-Medical)​

Your company may not be able to justify having designated internal signatories, or you may be experiencing a crunch whereby resources are stretched.  If so, Pharma Integrity can provide you with both Medical and non-Medical review and approval services, including certification to UK and Irish standards.  Need a second opinion?  We’re also happy to be a touch point partner for challenges in interpretation and application of Code and legislative requirements.

Services

PMCPA audit / HPRA inspection readiness analysis​

How confident are you that your Compliance framework and its adoption throughout your organisation will fulfil the requirements of a PMCPA audit / HPRA inspection?  Pharma Integrity will work with you to understand how to prepare your organisation, conduct analyses to provide feedback on what’s going well and where there may be room for improvement.  We will provide you with a written report that you can use to demonstrate your company’s positive culture and commitment to engaging with compliance requirements.

Services

Design & implementation of bespoke Compliance programmes

Design and implementation of bespoke Compliance programmes: Whether you are establishing a Compliance function for the first time, or you want to redevelop an existing organisation, Pharma Integrity can offer you insights relevant to your business needs and design the framework which you can use over many years.

Services

Compliance Manager mentorship

The role of a Compliance Manager can often be a lonely one.  You provide a lot of support to your business and colleagues, but what about you?  Who can you go to to bounce ideas off, run through scenarios, sense check your opinions?  What about your own personal development to help you grow in your role and responsibilities?  What are your blind spots?  Pharma Integrity offers one-to-one mentorship to a range of junior and experienced Compliance staff.  For some this is over a short defined period of time, for others it’s a long-term relationship.  Ultimately it needs to work for you and what you’re trying to achieve so there are numerous options available.  Call us to talk about where you’re at, and where you’d like to get to.

Services

Interim & ad hoc support ​

Do you have a stop-gap need that you need to fill?  Speak with Pharma Integrity to understand how we might be able to support you with some interim solutions and options.

Services

Support in responding to, and initiating complaints​

It’s a reality that companies may occasionally need to initiate or respond to inter-company dialogue or complaints involving authorities and regulators.  Understand your company’s options, formulate and execute a strategy, and respond accordingly with Pharma Integrity providing you insight and hands-on support throughout.

Services

Support of company TOV disclosures

Understand and apply the transparency requirements for pharmaceutical companies in the UK and Ireland.  What are the mandatory disclosures, what is recommended best practice?  When is consent applicable, and when is it not?  Who needs to be notified, and by when?  What information needs to be present on what platform, and how do you manage this over the disclosure term? 

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