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
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
HPRA inspection readiness analysis
How confident are you that your Compliance framework and its adoption throughout your organisation will fulfil the requirements of a 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
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?
Services
Advisory Board Support
We offer ad hoc support for your advisory board needs, catering to all stages from conception to execution. In case you require a more comprehensive solution, we also provide an end-to-end advisory board solution.
Services
End-to-end Advisory Board Solution
Our comprehensive solution ensures that your advisory boards run smoothly while adhering to compliance regulations. We take care of every step, starting from defining your company's objectives, refining them, setting the agenda, creating relevant assets, finalising the contracts, and hosting the adboard's proceedings. Additionally, we prepare a detailed report and provide assistance with notifying the relevant regulatory authority. Our team also helps in obtaining necessary approvals for all the required documentation at every stage of the process.
Training
2021 IPHA Self-Care Advertising Code (v6.0)
Previously known as the "Code of Standards of Advertising Practice for the Consumer Healthcare Industry", this updated Code incorporates traditional herbal medicines and consumer medical devices for the first time.
Engage us to help you train your staff on the new Code, and what it means for them.
Training
2021 IPHA Code of Practice for the Pharmaceutical Industry (v8.5)
The IPHA Code of Practice has underwent a significant update in 2021. All relevant staff need to know how these changes impact their role and responsibilities.
We can provide standardised or bespoke training for your company or department, taking into account the roles of those who will be participating to make the training as meaningful as possible.
Training
Bespoke Company "Compliance Day"
Do you want to reset the tone for Compliance within your company? Would you like to provide a more insightful overview of Compliance within the pharmaceutical industry and how it applies operationally within your company?
We have developed and delivered a number of bespoke "Compliance Day" initiatives to companies in the UK, Ireland, and across Europe, providing clarity on variances between countries and drawing together common themes to be considered in all cross-departmental roles.
Training
Medicines for Ireland Code of Practice
The alternative Code for members of Medicines for Ireland. We can provide new starter training or refresher training to companies adhering to the Medicines for Ireland Code of Practice & Medicines for Europe Code of Conduct.