Pharmaceutical development

. European quality and standards
.eCTD compilation
. Thorough consideration for MENA region requirements including stability zone IV and IP services
. Continuous update for the development to adapt the recent changes by the health authorities
. On site supervision for the validation, scale up and stability initiation
. Proactive approach that will help the partner to develop generics with added value (super genrics)
. Strong trouble shooting capabilities that will support the project
. IP assessment


. Wide range of tests.
. Helping our partner to improve the microbiological environment
. Very high quality service with affordable prices

Permeability studies

. We develop and validate a tissue culture model for permeability studies through Colon Carcinoadenoma Cells that will help to evaluate non-previously tested substances

. Proven track records in various studies that resulted in successful results that has been accepted by competent Health Authorities


. Working closely with the client and the health authorities to ensure successful study design and acceptable end points

Clinical trials management

. Helping our clients to design the studies required for each particular project; furthermore supervise the execution of the study

Pre-clinical Research

. CaCO-2 permeability studies for the sake of getting bio-waiver
. In-Vitro release studies for topical products
. Development and establishment of quality and pharmacovigilance systems for different companies
. Toxicity Studies for impurities qualification and for herbal products safety evaluation


.Turn Key project from GMP design, getting regulatory approval ,outsourcing equipment and machinery , developing quality systems, development and registration of products
. Development of quality system including process validation , cleaning validation , QbD Pharmaceutical development


. Providing full Pharmacovigilance system
. Customization and implementation
. Provision of training with real case studies
. Preparation of risk management plans and PSURs

Intellectual property

. Providing patent search services internationally , locally and in the GCC
. Providing consultation leading to freedom to operate when possible
. Preparation of eCTD dossiers
. Providing technical and regulatory support for answering registration deficiencies
. Technical and regulatory feedback and support for pharmaceutical product acquisition/outsourcing due diligence