Service Portfolio

Our team of scientists, project managers and technical professionals progress compounds from lab bench to first in man (translational medicine) and from first in man to out-licensing point or commercialisation in the most cost effective and efficient way.

Key Services:

• Pharmaceutical Development: Pre-clinical, CMC and Clinical Aspects
• Regulatory Affairs: Product concept to registration & commercialisation
• Supplies Management: Recruitment & management of 3rd party suppliers
• Compliance: GxP & QP Services
• Medical Devices: CE marking & manufacturing
• Funding Support: Compilation of funding submissions
• Investor Support: Technical due diligence & post investment evaluation

Drug Development Experience:

• Compounds: Small molecule, peptides, hormones & biologics
• Routes of administration: Sub-cutaneous, injectables, orals, topicals & inhalations

Regulatory Experience:

100% success on all 28 submissions presented to date. This experience is balanced between new drug applications and new product applications:

• USA = 50% split: 25% INDAs / 25% NDAs
• EUR = 50% split: 25% CTAs / 25% NDAs