Our Services
1. Regulatory Affairs Support:
- Registration: - Human Drugs, Veterinary, Dietary Supplements, Biocidal Products, Medical Devices, Cosmetics, Biological Products - International Registration File (CTD & ECTD)
- Licensing: Pharmaceutical factories, scientific offices, Stores & warehouse licensing, Importers registration license.
- Monitoring Custom Release: Import, Export .
- CMC documentation management
- Formulation development and manufacturing advice
- CMC project management
2. Pharmaceutical Solutions & Consultancy:
- Factory Assessment - Technical assessment report (TAR): - Pre qualification & internal Auditing for GMP, GSP, GLP, GDP (WHO, EMEA guidelines) - Pre qualification & internal Auditing for ISO 9001, 14001, 18001 - QA, QC , R&D, Production Support - Process analysis, process maping - Process Continual improvement support (Six Sigma Tools) - Validation (process, analytical method, computer system…etc)
- Agreements : Conduction of any agreement between two parties concerning manufacturing, distribution,
- Storage, buying & selling products…..etc .
- Software (RIP, ERP, CRM, LIMS,…etc) : All software enhancing and speeding up processes efficiently and effectively
- Due Diligence: - Several investigations and assessments done prior to signing a contract or dealing with a project. - The examination of a potential target for merger, acquisition, privatization or similar corporate finance transaction normally by a buyer. - We perform Due diligence for Companies, Factories & Products
3. Marketing Solutions:
- Co-promotion Agreements: Agreements between two parties concerning the marketing and promotion of the product.
- Marketing Research: Researches done prior to entering a new market or to define a problem facing the company and finding a solution to it.
- Marketing Plans: Preparing IMC plans and marketing campaigns for your products.
4. Designs & Artwork :
- Logo Designs
- Brochures
- Inner & Outer Label Forms
- Package Design
- Cards, Letterheads,etc. .
5. Company Formation:
- Egypt.
- USA.
- Gulf Area.
- Europe.
- North, East and West Africa.
6. Exportation Activities:
- All Exportation activities for products, devices…etc
- Registration of Pharmaceutical, cosmetics, Medical Device Worldwide.
- Agency Agreement.
- Exportation Approvals.
7. Global and local Pharmacological Services:
- QPPV & Pharmacovigiance Systems.
- Safety Data Management & Signal and Benefit Risk.
- Literature Screening and periodic Reporting
- Medical Device Vigilance