Confidence Beyond Compliance
With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad
global project experience to meet your specific needs, from discovery to licensing and post-approval.
If you would like to register your interest in a training session or strategy workshops (remote or face-to-face), please contact us using the link below.
We offer support in the following areas
- Development and regulatory strategy considering regional requirements (e.g. US, EU, Canada, Japan, Emerging Markets)
- Gap Analysis / Due diligence
- Technical writing and compilation of regulatory documents
- Scientific advice and other health agency meetings
- Risk assessment
- Preparation of TPP
- Comparability exercises
- General ‘troubleshooting’, including investigations and root cause analysis and
support for CAPA
- Deviation and change control preparation / review
- Method / process validation
- Process characterization
- Project management
PharmaLex provides services across the product lifecycle
- 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.