Proven methodology for long term success
Confidence Beyond Compliance
The biopharmaceutical sector already makes up at least 20% of the global pharma market with a foreseeable growth in the future. Reasons for this are the outstanding efficacy and safety of these complex molecules, and their high potential to address historically untreatable conditions. The development and production of biopharmaceuticals are both challenging and evolving rapidly, and so are the associated regulatory expectations and pathways to approval. It is essential to account for regulatory requirements early on and to carve out the most efficient path to approval to ensure commercial success.
PharmaLex is able to offer an integrated solution combining the scientific, technological, non-clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.
We Support a Range of Products
- Recombinant proteins (including mAbs (and derivatives), hormones and enzymes)
- Vaccines (recombined proteins, live attenuated bacterial vectors, viral vectors)
- Cellular tissue cell and
- Gene therapies / ATMPs
PharmaLex Offers Support In These Area
- Clinical Development
- Discovery / Non-Clinical
- Market & Launch
- Product Maintenance
More Free Webinars
- Optimize your biosimilar development strategy
Zeb Younes, Director, Regulatory Affairs
A well planned, controlled development program will ultimately lead to a successful international drug development program.
- Understanding the Regulatory Landscape for Tissue, Cell and Gene Therapy Development
Dr. Zaklina Buljovcic, Director, Principal Consultant Innovative Therapies
Learn about what Advanced Therapies in the EU, gain an understanding of existing regulatory tools and how to use them, and gain insights into US Tissue, Cell and Gene Therapy regulations.