A Jordanian limited liability company was established in 2010 by a group of qualified people having extensive knowledge and experience in research and development in the pharmaceutical industry. Due to the broad spectrum of pharmaceutical services managed at highest standard level, the company has been recognized as one of the fastest growing companies in the region in 2011 & 2012 (all world network and Harvard business school classification). The pharmaceutical research and services provided include the following:
1. Technology transfer projects which consist of the R&D of pharmaceutical products and the transfer of such knowledge. These include providing a standard documentation including: product composition, manufacturing process, in-process control, specifications of starting materials and finished products, method of analysis for the starting materials and the finished products, validation of the method of analysis, stability studies, and others.
2. Analytical services (physical, chemical, microbiological) for the pharmaceutical, cosmetic, herbal, food, and medicinal industry. The analytical services include: testing of finished product, testing of active ingredient and impurity profile, stability studies, comparative dissolution studies, in-vitro release from semisolid products, microbial testing, toxicological studies, pharmacodynamics studies using comparative enzymatic assay, and others. The microbial lab is qualified to provide total microbial count, microbial contamination, bioassay, preservative effectiveness, environment control, sanitizer efficacy test, LAL (limulus amebocyte lysate) test.
3. Consultation and regulatory services. Those include GMP( good manufacturing practice) consultation including site layout, documentation system, training, common technical document (CTD) filling prepared at the highest international standards, response to deficiency letters, translation of leaflets and patents, clinical and non-clinical expert reports, monitoring and auditing of bioequivalence studies, file registration and follow-up, quality overall summary, periodic safety update reports , re-registration file review and update, and others.
Through the pharmaceutical engineering services provided with the collaboration with international engineering companies and manufacturers of machinery and utilities, the company can provide turn-key projects including a validation master plan and a full documentation system.
The company’s pipeline include: CNS (central nervous system) portfolio, CV (cardiovascular) portfolio, HCV (hepatitis C virus) portfolio, oncology, injectable products, development of novel combination and super generic products with proven safety and efficacy, novel manufacturing process development for challenging drugs, development of OTC (over-the-counter) products, standardized herbal medicine, and others.
New type of projects were developed by the company including: integrated API (active pharmaceutical ingredient) synthesis supply with dossier agreement especially for HCV (hepatitis C virus) and MS (multiple sclerosis) products, in addition to the manufacturing and supply of niche medicated cosmetic pipeline in the MENA region.
The company’s tech transfer projects, services, and products are available in 24 countries including EU countries. In addition, the company was involved in many research projects in different areas and several were published in international journals.
In 2016, the company was making successful access to new markets using different business models with a turnover of about 2.4 M Euro. So the company is open to offer its research capacity and pharmaceutical services to develop products, technical know-how, and registration dossiers as well as providing other consultation and analytical services by a service agreement, or helping start-ups to create their innovative market-driven products to be ready for production through an outsourcing agreement.