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ATMP Regulatory and Development Support for Advanced Therapy Medicinal Products and Cellular and Gene Therapy

Advanced Therapy Medicinal Products (ATMPs) — known in the United States as cellular and gene therapy — represent a new generation of transformative treatments, including gene therapy medicinal products, somatic-cell therapy medicines, and tissue-engineered products, designed to repair, replace, or modify biological functions at their source. While the scientific potential of these therapies is extraordinary, bringing ATMPs to market requires navigating complex regulatory pathways, specialised manufacturing standards, and long-term safety monitoring requirements — challenges that demand experienced regulatory and development partners.

Billev Pharma East provides integrated expertise for innovators developing Advanced Therapy Medicinal Products and cellular and gene therapy at every stage — from early development and regulatory strategy to GMP manufacturing readiness, pharmacovigilance, and patient journey optimisation — helping you accelerate development and bring your therapy to patients with confidence.

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End-to-End Support for Advanced Therapy Medicinal Products and Cellular and Gene Therapy

Developing ATMPs and cellular and gene therapy requires far more than scientific innovation. Advanced Therapy Medicinal Products must navigate a dedicated EU regulatory framework, meet specialised manufacturing requirements, and maintain robust long-term safety systems before they can reach patients.

At Billev Pharma East, we provide coordinated support across the entire ATMP and cellular and gene therapy lifecycle. Our multidisciplinary team combines regulatory affairs, clinical strategy, quality and GMP expertise, medical affairs, and pharmacovigilance — working as one integrated unit so that your programme stays aligned across all critical workstreams.

We help you design robust development strategies, engage productively with regulators from the earliest stages, and prepare your programme for clinical trial authorisation and marketing authorisation — without the delays that come from siloed advice.

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Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202

1000 Ljubljana

Slovenia

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Integrated ATMP Development and Regulatory Strategy for Cellular and Gene Therapy

The development of Advanced Therapy Medicinal Products and cellular and gene therapy differs fundamentally from traditional pharmaceutical development. Small patient populations, evolving regulatory guidance, and complex product characterisation require adaptive clinical designs and proactive regulatory dialogue — not a standard template.

In the EU, ATMPs are governed by Regulation (EC) No 1394/2007 and assessed through a centralised procedure by the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). Regulatory expectations span preclinical evidence, clinical design, and chemistry, manufacturing and controls (CMC) — and all three must be aligned from the outset to support a credible path to approval.

Billev Pharma East develops phase-appropriate regulatory strategies tailored to your ATMP class and development stage. We support Scientific Advice preparation, IMP dossier authoring, and CAT engagement — ensuring that every development decision reinforces your regulatory position rather than creating future risk.

Get expert support for your ATMP development

Cellular and Gene Therapy Manufacturing and ATMP GMP Compliance

Manufacturing is one of the defining challenges in the development of ATMPs and cellular and gene therapy. These products involve highly complex processes, personalised treatment workflows, and strict traceability requirements across the entire production chain — from starting material to final product.

Advanced Therapy Medicinal Products must comply with EU GMP Annex 2, the dedicated GMP framework for ATMPs and cellular and gene therapy, which addresses starting material qualification, process characterisation, product consistency, and quality system requirements specific to these therapies. Establishing a compliant manufacturing process early is essential — delays in GMP readiness frequently become the critical path bottleneck during clinical development and regulatory review.

Billev Pharma East provides specialist GMP consulting and Qualified Person (QP) services, including EU QP certification of ATMPs and compliant batch release in accordance with European regulatory requirements. We help you build a manufacturing and quality system that regulators trust — from first GMP run through to commercial scale.

Medical and Safety Expertise for Cellular and Gene Therapy and ATMP Lifecycle Management

The clinical development of cellular and gene therapy and Advanced Therapy Medicinal Products demands careful, ongoing evaluation of both therapeutic benefit and long-term risk. Because these therapies can produce durable or permanent biological effects, safety monitoring obligations extend well beyond the initial treatment period. For gene therapy medicinal products in particular, EMA requires structured long-term follow-up of up to 15 years post-treatment.

Regulatory authorities expect robust pharmacovigilance systems, risk management plans (RMPs), and long-term follow-up protocols to be in place before and throughout the product lifecycle. Generic PV templates are not appropriate for Advanced Therapy Medicinal Products — the system must fit the modality.

Billev Pharma East builds and manages ATMP-specific pharmacovigilance frameworks — including PSMF development, RMP authoring, ICSR handling, PSUR preparation, and long-term follow-up programme design — as well as providing integrated medical oversight across clinical development and post-authorisation phases.

Optimising the Patient Journey for ATMPs and Cellular and Gene Therapy

For many Advanced Therapy Medicinal Products — particularly autologous cellular and gene therapy — the patient journey is not just a commercial consideration. It is a structural element of your manufacturing and regulatory programme.

Autologous cellular and gene therapy places the patient at the centre of the manufacturing supply chain. EU regulations require chain-of-identity traceability from material collection to product infusion, and only qualified treatment centres are authorised to administer these therapies. The pathway from diagnosis to treatment typically involves specialist referral networks, site qualification requirements, and rigorous logistics coordination.

Billev Pharma East maps and optimises your end-to-end patient journey — from diagnosis and referral pathways to treatment centre qualification and post-infusion follow-up. We help you move from a site-to-patient model to a patient-to-site approach, reducing vein-to-vein time and improving access for the patients who need these therapies most.

Accelerating Market Access for Advanced Therapy Medicinal Products and Cellular and Gene Therapy

Bringing ATMPs and cellular and gene therapy to market requires more than successful clinical development. Under EU Regulation (EC) No 1394/2007, Advanced Therapy Medicinal Products must obtain a centralised marketing authorisation — assessed by the CAT and approved through the CHMP — before they can be marketed across the European Union. There are no national shortcuts.

Achieving that authorisation efficiently demands that regulatory strategy, CMC development, manufacturing readiness, and lifecycle safety management are coordinated from the earliest stages. Programmes where these workstreams are misaligned routinely face avoidable delays at the most critical milestones.

Billev Pharma East integrates all of these disciplines under a single team, giving your ATMP and cellular and gene therapy programme a coherent and inspection-ready development path — from first-in-human to CAT-approved marketing authorisation and commercialisation.

How Billev Pharma East Supports Your ATMP and Cellular and Gene Therapy Programme

Developing Advanced Therapy Medicinal Products and cellular and gene therapy requires expertise that spans regulatory affairs, clinical development, GMP manufacturing, medical affairs, and long-term pharmacovigilance. Under EU Regulation (EC) No 1394/2007, these therapies must undergo a centralised marketing authorisation process before reaching patients.

Billev Pharma East brings together all of the disciplines needed to support your ATMP or cellular and gene therapy programme across its full lifecycle. Our team works directly with EU national competent authorities and the European Medicines Agency, helping you align your development strategy with regulatory expectations and build the evidence base your submission needs.

Our integrated service offering covers:

Preclinical strategy Risk-based study design, species-specific models, CTA-ready data packages for ATMPs and cellular and gene therapy
Clinical development Adaptive trial design, master protocols, DSMB governance, long-term follow-up planning
Regulatory / CMC IMP dossier and MAA quality module authoring, Scientific Advice preparation, CAT and CHMP engagement
GMP manufacturing support EU GMP Annex 2 compliance, QP services, batch release, inspection readiness for cellular and gene therapy and tissue-engineered products
Medical affairs Benefit-risk strategy, investigator support, post-authorisation evidence generation
Pharmacovigilance PSMF, RMP, ICSR, PSUR, long-term follow-up protocols (including 15-year LTFU for gene therapy)
Patient journey Chain-of-identity traceability, referral pathway design, treatment centre qualification

This integrated approach gives organisations developing Advanced Therapy Medicinal Products and cellular and gene therapy a clearer path, stronger compliance, and a more efficient route to patient access — with one partner accountable across the full journey.

Navigate ATMP regulations with confidence

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With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.

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