Scene 1

Provides regulatory-grade service to pharmaceutical & biopharmaceutical manufacturers. 

Scene 2

Provides regulatory-grade service to pharmaceutical & biopharmaceutical manufacturers

Fast-track, Cost-effective Consultancy Services

Support development of safe & effective quality medicines

Pharmaceutical Industry Modernization & Localization

Help manufacturers in placement of innovative & different disciplines in addition to  benchmarking of them against regulatory requirements

Unique & Advanced Lab Infrastructure. Data Integrity by LIMS Thermo-Fischer SM Version 12.3. 

Scene 3

Data Integrity by LIMS  Thermo-Fischer SM Version 12.3

ISO/IC 17025:2017 Accreditation For Testing & Calibration Laboratories

ISO 17034:2016 Accreditation For Certified Reference Materials

Well-equipped core facility that designed according to GLP

REFERENCE LAB SERVECIES. Pharmaceutical Product Development Biologics & Biosimilars Development Cosmeceutical product development Biocompatibility studies of Medical Devices Cell-based assays & Pre-clinical Studies Certification of Reference Materials. 

Scene 4

Pharmaceutical Product Development Biologics &  Biosimilars  Development Cosmeceutical product development Biocompatibility studies of Medical Devices Cell-based assays    & Pre-clinical Studies Certification of Reference Materials

PHARMACEUTICAL PRODUCT DEVELOPMENT. RESEARCH AND DEVELOPMENT. 

Scene 5

API characterization formulation studies  Scaling up & technical transfer CTD file

All types of pharmaceutical dosage forms Using 7 types of dissolution App. (1,2,3,4,5,6&7) Fast track against bio-batch instead of innovator

Assay of active ingredient of herbal extracts Herbal Products Related substance & impurities

Ultra-trace determination of related substances Analysis of pharmaceuticals in biological matrices

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

Raw materials Finished products (Analytical & dissolution method development)

1. BIOLOGICS & BIOSIMILARS DEVELOPMENT. 2. Bioanalytical method development & validation for Raw materials and finished products. 

Scene 6

Bioanalytical method development & validation for Raw materials and finished products

Bio similarity assessment on regulatory bases (CTD file for  biosimilars )

Biosimilar & Biological product development (CTD file for biologicals)

COSMECEUTICAL PRODUCT DEVELOPMENT. 2. Safety assessment as per EU guidelines like heavy metal testing by (ICP). 

Scene 7

Safety assessment as per EU guidelines like heavy metal testing by (ICP)

Cosmeceutical assessment like SPF limit testing

Notification system as per EU directions (EGY COSMO)

CERTIFICATION OF REFERENCE MATERIALS. Certification of Reference material Elemental impurity analysis Related substance and impurity Sharing of CRM data base. 

Scene 8

Certification of Reference material Elemental impurity analysis Related substance and impurity Sharing of CRM data base

Physical description & performance testing  Qualitative & Quantitative chemical assay of devices in a pharmaceutical dosage forms  Bio compatibility on different animals & strains including implantation – chronic & sub chronic toxicity  In-vivo testing (irritation test–sensitization–acute/sub acute systemic toxicity)& In-vitro testing (cytotoxicity)

Pre-clinical (In-vivo) studies in accordance to GLP requirements on  biosimilars  and new drugs  Cell-based assay ( ligand binding assay)

PowerPoint Presentation

Scene 1 (0s)

Scene 2 (6s)

Scene 3 (23s)

Scene 4 (46s)

Scene 5 (57s)

Scene 6 (1m 28s)

Scene 7 (1m 43s)

Scene 8 (1m 59s)

Scene 9 (2m 26s)