Medicines Access

Early / Managed Access Programs

During a clinical trial, patients might not be able to access a trial medicine because they do not meet the inclusion criteria or do not have access to the trial.

After a trial, a medicine may not make it to market in certain countries, or a patient may need to continue treatment until it does.

When a clinical study ends, BAP Pharma can supply medicines for patients who need to be maintained on therapy level support until the commercialisation and launch of the treatment.

Our experts in Early and Managed Access Programs (EAP/MAP) can assist and support your efforts to bring critical treatments to patients in need, ensuring they get the medicines they need, when they need them, anywhere in the world.

Our global network can provide ongoing consultation and support in the areas of:

  • Regulatory Affairs / Country Licenses
  • Quality Assurance
  • Documentation
  • Submissions
  • Supply Chain
  • Real World Data Capture
  • Reimbursement
  • Market Insights and Access to new markets

 

 

Patient Centricity

Patients’ needs come first, and we design our services with their well-being as our central focus. Here’s how we ensure that every step of our process prioritizes the patient experience:

Tailored Programs for Patients

We design our programs to meet each patient’s specific needs.
We provide clear, upfront information to patients and healthcare providers, so they know exactly what to expect from the process.
All documentation and educational materials are translated into local languages wherever possible.

Support Throughout the Process

We provide full support from the moment an order is placed and establish clear timelines, so patients know when to expect their treatments.

Timely Access to Medicines

We know that waiting for life saving medicine is stressful and overwhelming, so we ensure that medicines are supplied as quickly as possible.

Empowering Pharma with Real-World Data

Our programs also help pharmaceutical companies better understand their medicines through real-world data collection.
This data enables pharma companies to refine their products and delivery, ultimately benefitting more patients in the future.
By focusing on real-world outcomes, we help improve treatments and access pathways for patients globally.

Collaborating with Patient Advocacy Groups

We work closely with patient advocacy groups to raise awareness about managed access programs and educate communities about this vital pathway for patients to access lifesaving medication.

Post Trial Access

BAP Pharma provides Post Trial Access (PTA) when a patient needs to continue their course of medicinal product once the clinical trial concludes, ensuring a seamless transition from clinical trial participation to ongoing treatment access.

Real World Data Capture

Real World Data on EAP/MAPs gives pharmaceutical companies actionable insights that extend beyond clinical trials, supporting broader decision-making in regulatory, clinical, and market access strategies as observed in diverse patient populations.

Real World Data applications:

  • Insights into Drug Safety and Efficacy
  • Monitoring adverse events
  • Side effects
  • Overall safety profile
  • Understanding of Treatment Pathway
  • Supporting the Drug Approval Process
  • Identification of Populations with Enhanced Benefit/Risk Ratio
  • Development of Evidence to Support Expanding the Indication for an Asset
  • Pricing and Reimbursement Intelligence to Support Commercialization

Secondary Packaging & Labelling

The BAP Pharma Secondary Packaging and Labelling team is integral to the success of our Medicines Access programs with the ability to manage the complex labelling requirements for global programs.

  • Labelling operations at each of our three global sites
  • End-to-end support
  • Advising on country-specific labelling requirements
  • Designing compliant clear labels
  • Quality release expertise

Global Medicines Shortages

Drug shortages can impact patients anywhere and at any time and providers of medicines access services are increasingly in demand whether due to supply chain issues or a lack of specific active pharmaceutical ingredients (APIs).

At BAP Pharma, we specialize in handling global drug shortages, providing end-to-end solutions that bridge supply gaps and prioritize patient wellbeing.

We are experts in every territory’s regulations, their customs processes, and in navigating complex supply chains.

With our extensive network of trusted suppliers and manufacturers, we are equipped to respond swiftly and effectively to drug shortages wherever they arise.

With BAP Pharma, you can trust in a partner dedicated to delivering responsible, reliable, and compliant solutions for global drug shortages. We are here to make a difference – one shipment, one patient, and one solution at a time.

Our services include:

  • Global Sourcing
  • Regulatory Expertise
  • Seamless Distribution
  • Patient Centric Solutions
Image

Upcoming Events

Organiser

Clinical Trial Supply East Coast

  • 4th - 5th Nov 2025
  • King of Prussia, USA
BOOK TIME WITH US THERE
Organiser

CPHI Frankfurt

  • 28th - 30th Oct 2025
  • Frankfurt, Germany
  • 4.1N24
BOOK TIME WITH US THERE
Organiser

World Orphan Drug Congress

  • 27th - 30th Oct 2025
  • Amsterdam
BOOK TIME WITH US THERE
Organiser

ESMO

  • 17th - 21st Oct 2025
  • Berlin
BOOK TIME WITH US THERE