PHARMADATA

Company Profile

Pharma-Data focuses to regulatory affairs, business and product development offering fully integrated, customized to sponsors, state-of-the-art and cost effective services.

Following the continuously complexity of the pharmaceutical legislation and demands, Pharma-Data is focused on the provision of:

• High-quality, state-of-the-art registration dossiers for pharmaceutical products
• Contract development of pharmaceuticals products.
• regulatory affairs consulting.
• Business development services.
• Licensing opportunities (-in & -out).

Our main goal is to offer top services to our partners, succeeding the establishment of critical agreements and win-win collaborations between parties.

Target Partners & Collaborations

Pharma-Data is seeking for partners and customers for new product developments, co-developments, dossier updates, tech-transfers and development of innovative technologies (hybrid applications, generic-plus etc.).

Technologies / Services offered or sought

• Extensive research for USE, API and FORMULATION patents (in-house and/or by specialized patent attorneys)
• Thorough investigation in the best facility for Drug Product pilot and commercial batches contract manufacturing
• Formulation development
• Design and Validation of Analytical methods (according to ICH guidelines)
• Robust and cost-effective manufacturing process development and optimization
• Process validation (ICH guidelines)
• Stress Studies
• Stability studies (ICH guidelines)
• Compatibility studies/ in-use stability studies
• Bioequivalence studies (using the highest skilled specialized CROs worldwide)
• Dossier compilation and submission
• Preparation and follow-up of National, MRP and DPC applications
• Post-approval regulator support, (variations, updates, renewals, etc.)
• Dossier update
• Tech and method transfers

Pharma-Data can work as one-stop CRO from API to eCTD dossier, galenical development, analytical services, ICH stability to our ISO and EU-GMP approved and soon FDA compliant R&D laboratory.

Clients & Collaborations (INTERNATIONAL)

Pharma-Data is seeking for partners and customers for new product developments, co-developments, dossier updates, tech-transfers and development of innovative technologies (hybrid applications, generic-plus etc.).