Enterprise Europe Network

A leading Jordanian pharmaceutical company with a broad spectrum of high-level research, product development, consultancy, and analytical services seeks a service or outsourcing agreement.

Country of origin:
Country: 
JORDAN
Opportunity:
External Id: 
BOJO20180726004
Published
30/07/2018
Last update
28/08/2018
Expiration date
29/08/2019

Keywords

Partner keyword: 
Pharmaceutics
Medical Research
Pharmaceutical Products / Drugs
In vitro Testing, Trials
Toxicology
In-vitro diagnostics
Molecular diagnosis
Oncology
Pharmaceuticals/fine chemicals
EXPRESS YOUR INTEREST

Summary

Summary: 
A Jordanian fast growing pharmaceutical research company, established in 2010, is specialized in the development of pharmaceutical products with outstanding quality and market-potential. It also prepares regulatory filing to international standards, in addition to providing several analytical, consultancy and regulatory services. The company is looking to expand its business by offering its services to other regions, mainly to the EU countries, either via a service or an outsourcing agreement.

Description

Description: 

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.

Advantages & innovations

Cooperation plus value: 
The company and its laboratories is ISO/IEC 17025 certified, “Jordan food and drug administration – JFDA” certified, ISO 9001 certified, ISO 13485 certified which is the pre-requisite to obtain the CE mark for its products, and GMP (good manufacturing practice) certified. The company was inspected too by European contract research organizations (CROs) in Austria and by a Swiss pharmaceutical company, and has been approved for conducting various analytical testings’ for finished products. It has been also inspected by the “Jordan accreditation system” (JAS) which received the international recognition as an international accreditation body from the “international laboratory accreditation cooperation”, so the company is accredited worldwide as a reference laboratory. The company consists of experienced and dynamic R&D team working in disciplined manners according to preapproved protocols. The company is market-driven focusing on market needs and is well-oriented to market trends. The company was the pioneer in several research projects. It had developed a couple of new innovative drugs and had developed an internal process that explores market needs and pharmaceutical trends, and translates those project ideas on the ground by developing and introducing new products in different markets. The company has been extensively investing in human resources, instrumentation and facility leaving no barriers to prevent the company from developing complicated or advanced dosage forms. The company consists of experienced executives of 20 years of experience in average in the field of work. The facility is a five-storey building on a land area of 1080 sqm which has a working area of more than 2500 sqm that has all the state-of-the art machines and equipment. The company is also committed to create business for pharmaceutical entrepreneurs and start-up projects through pipeline development and consultation. In 2015, the added value to pharma industry exceeded $150 Million

Stage of development

Cooperation stage dev stage: 
Already on the market

Partner sought

Cooperation area: 
The company is open to provide service agreements to develop pharmaceutical product technical know-how and registration dossiers as well as providing other contract services. The partner should be within the pharmaceutical industry that is willing to develop a new product and prepare its regulatory filling at international standards. Or the partner is looking to obtain other pharmaceutical consultations and analytical services. In addition, the company is willing to cooperate with CROs (contract research organizations) in an outsourcing agreement with ready-to-access diverse patient database to perform bioequivalence studies.

Type and size

Cooperation task: 
SME 11-50,Inventor,R&D Institution,SME <10,SME 51-250,>500