Regulatory Strategy: Guiding Your Innovative Product to Success

PharmaLex, now part of Cencora, is a full service regulatory consultancy serving the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities.

Providing the right services be it to small or large companies or academia:

Being part of a large internal network means every client, regardless of size, can select the solution or service that fits your current situation.

We understand the needs of start-ups and academia early in development. Our support spans development of assays and manufacturing controls, set-up of nonclinical plans up to first-in-human trials, development of clinical strategy, writing, statistical support, GxP services, paediatric development, scientific advice meetings, authoring of dossiers for marketing authorisation, expedited pathways (e.g. EAMS, ILAP, PRIME) and respective services for other regions in the world (e.g. FDA, Health Canada, TGA) if required

As a partner it is important to us that you feel well attended, so in each project, you will receive an individual contact person and you will be working with a dedicated team, committed to delivering reliable and continuous partnership throughout the project.
As your projects expand, we can support your growth as needed. This includes helping you with larger clinical trial programs, supporting formulation and quality development.
Additionally when the time has come we can be handling the logistics with your innovative study medication, managing applications for marketing authorization around the globe, and providing support for market access and reimbursement strategy.

Experience

Our experts have academic backgrounds and first-hand research experience. When combined with our know-how in the regulatory field, this enables us to review development programs critically both from a scientific and a regulatory perspective. Many of our experts have worked with and for regulatory agencies and can provide in-depth consulting on niche areas relevant to biologics and cell therapies and other innovative products.

Our track-record includes EU-funded Horizon Europe programs (e.g. iPSpine and INSPIRE), coaching within governmental programs to help developers streamline their programs and making efficient use of public funds.

A team of more than 60 experts in different drug types, therapeutic areas and disciplines (CMC, nonclinical, clinical, statistics, market access) is ready to support you.

Listen to our experts  Dr. Angela Vogt-Eisele and Dr. Zaklina Buljovcic share their insights during the presentation: “Regulatory Strategy: Guiding Your Innovative Product to Success” on April 10th from 12:50-13:20
And connect with us at Booth 9, where we look forward to answering your questions.

Key facts :

200+ clients in ATMP field
100+ vaccines, incl.  
15+ COVID vaccines
30%+ of all EU MAAs for ATMPs supported by PharmaLex
20+ years of experience working with ATMP regulators
60% + of our clients are small and midsize enterprises

30 + projects with academic insitutions

40+ EMA / FDA / MHRA / PMDA / NMPA health agency meetings per year

Scope of Experience (non-exhaustive list)

• Viral vectors
• Genome editing
• Gene therapies
• Cell-based therapies
• Induced pluripotent stem cells (iPSCs)
• Immune cell therapies
• Vaccines
• Personalized immunotherapies/ cancer vaccines
• Monoclonal antibodies (mABs)
• Antibody-drug conjugates (ADCs)
• Biosimilars
• Recombinant proteins
• Innovative small molecules
• Bacteriophages
• Microbiome
• 3D printing

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