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Psilocybin strategic insights 

The therapeutic revolution of psilocybin is becoming a treatment reality. We can help your company to navigate the regulatory, policy, and access landscape in the UK, EU, US, Australia, and globally to unleash innovation for a brighter future.
What is Psilocybin | Medical Writing | Bham Pharma

What is psilocybin?

Psilocybin is a naturally occurring molecule found in over 200 species of fungi. In structural terms, it is similar to serotonin which is a human neurotransmitter that regulates our mood and perception. When psilocybin is administered in a clinical setting with appropriate psychological support, early clinical trials show that it may be an effective treatment for multiple mental health conditions, particularly for patients for whom other treatments have been ineffective.

Psilocybin and its therapeutic potential 

We understand that psilocybin-based research is evolving at speed with a range of clinical trials taking place in multiple countries across the globe. Equally, we realise that psilocybin has therapeutic potential for an array of debilitating conditions including treatment-resistant depression, alcohol use disorder (AUD), and post-traumatic stress disorder (PTSD).

We have critically appraised the maturing psilocybin evidence-base and psilocybin-related business trends in the UK, EU, US, and Australia. With the advent of compelling clinical trial data, we feel that now is the time to partner with those who are spearheading psilocybin-based innovation. We want to provide our passion and expertise in realising the therapeutic potential of psilocybin in the months and years ahead. We have a clear call to action:
To partner with those who are driving psilocybin-based innovation to transform unmet therapeutic need based on evidence and action globally.

Our psilocybin offering

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Psilocybin medical writing and regulatory documentation support for drug development

From molecule to market, we can deliver all psilocybin-related documents you need throughout the clinical trial process on time, on message, and on budget.  

Psilocybin-based political, policy and regulatory intelligence

Accurate political, policy, and regulatory intelligence is essential in understanding the ever-changing life science environment in which we operate. We can provide you with contemporary psilocybin-based intelligence and strategic counsel which can guide your internal decision-making and broader commercialisation ambitions.
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Psilocybin-based value dossiers and desk research

We understand that detailed desk research is both time consuming and laborious. Our team of experts can research, analyse, and create evidence-based value dossiers in an array of format a to support your internal decision-making and broader commercialisation strategy.

Stakeholder mapping reports 

We can identify all the relevant stakeholders needed to support your psilocybin communications and engagement activities. From clinicians, patient groups, charities, and academics we can help you to understand who is doing what, where, when, and how in relation to psilocybin in the UK, US, EU, Australia, and elsewhere. Whatever information you need, we can find it to support your short-term, medium-term, and long-term business strategy.

Bespoke desk research and report generation

Whatever your question or challenge, we can locate, analyse, and deliver valuable insights about the psilocybin landscape in the UK, EU, US, Australia, and elsewhere to support your market authorisation, reimbursement, and access needs.

A snapshot of the post-Brexit regulatory environment in the UK

We can help you to navigate the Innovative Licensing and Access Pathway (ILAP), Innovation Passport procedures, and other regulatory approval processes. Equally, we can provide you with up-to-date regulatory policy information from the Medicines and Healthcare products Regulatory Agency (MHRA), the Department of Health and Social Care (DHSC), The National Institute for Health and Care Excellence (NICE), the National Health Service (NHS), and other relevant agencies.   

Information on psilocybin drug scheduling in the UK and beyond

We can provide you with current information about the scheduling status of psilocybin in country-by-country information packs. Our information packs can also include data about public and governmental attitudes towards psilocybin, detailed political horizon scanning, epidemiological information relating to your therapy area, or indication of interest, and anything else you need to make your launch strategy a success.    

Our psilocybin policy and advocacy agenda

In the UK, psilocybin remains a Schedule 1 substance (as it does in some other countries). This means that psilocybin is viewed as a substance that is thought to have no therapeutic value and cannot be lawfully possessed or prescribed. The classification of psilocybin as a Schedule 1 substance is outmoded and evidence keeping psilocybin in Schedule 1 is wanting. Thus, Bham Pharma will do its part to advocate for psilocybin rescheduling and we will be seeking external engagement with those who understand the therapeutic and economic benefits that psilocybin rescheduling will bring to society both in the UK and elsewhere.  
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The future of psilocybin 

We are currently experiencing a renaissance in psilocybin-based research. Clinical trials for a range of conditions are taking place in countries all over the world. The therapeutic promise of psilocybin is growing in line with an increasing psilocybin evidence-base. Guided by current psilocybin-related clinical data and driven by the imperative to develop a data registry to support psilocybin rescheduling, Bham Pharma is here to partner with the thought leaders. We seek to work with those organisations and advocates who understand the future promise of this game-changing treatment that could transform health and wellbeing outcomes in the years ahead.

Require psilocybin insights?

Contact us through the form below and one of our team members will be in touch! 

Contact us

Contact us using the details below and we can set up a video call to discuss your project needs and how we can help you.
+44 (0) 1772 846 112
Preston, Lancashire, England, United Kingdom

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