Our Achievements

. NCT02493179 clinical study: Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation after Third Molar Surgery Sponsor: Hayat Pharmaceutical Industries Co. PLC
. NCT02328404 clinical study: The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance among Overweight Jordanian Women with Polycystic Ovary Syndrome in Irbid Sponsor: Hayat Pharmaceutical Industries Co. PLC
. Clinical reviews for European dossiers

Pre-clinical Research

. Developing state of the art cell culture lab for biopharmaceutics CaCO-2 permeability studies for the purpose of justifying biowaiver for several products. We were able to support biowaiver and granted bioequivalence approval from JFDA based on this in vitro research. The rationale behind this approach is to save the extra cost required for Bioequivalence studies and to reduce the un-necessary patient exposure during such clinical studies
. Toxicity Studies for impurity qualification that exceeds the ICH threshold
. Pre-Clinical reviews for European dossiers

Pharmaceutical Development

. Development of several first to market innovative products like Vitamin D, rosuvastatin , lornoxicam
. Reverse Engineering in meeting BCS Class III Biowaivering requirements
. A novel in-vitro assay using biorelevant markers capable of monitoring and screening the lipase inhibitors that could be used as anti-obesity agents

Current Projects

. Turn Key project for pharmaceutical manufacturing company
. Topical in-vitro release studies for different products to support bio-waiver of bioequivalence/end point clinical studies
. Development and establishment of quality and pharmacovigilance systems for different companies
. Development of new innovative/super generic products
. Development of generic products

Services

. Development of generic products including formulation development, analytical method development, analytical method validation/verification, Stability..etc
. Innovative product/super generic development: In addition to CMC work, we can provide integrative service through clinical research , pre-clinical or comparative bioavailability studies
. Regulatory consultations
. Troubleshooting

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

Quality

.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

Pharmacovigilance

. 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