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Contract regulatory and clinical research services, U.S. HQ with satellite offices in Taiwan and Europe.
FDA, EMA, etc. worldwide regulatory approval services for drugs, devices, and diagnostics.
Worldwide clinical testing for safety and efficacy

Canadian IVD company with core competencies in the fields of Thrombosis, Haemostasis and oncology, with innovative technologies, we collaborate internationally with technology development companies and health-care stakeholders to develop and manufacture customized reagents and diagnostic solutions.

Who We Are

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Cerevel Therapeutics is a clinical-stage biopharmaceutical company that combines a deep understanding of the biology and neurocircuitry of the brain with advanced chemistry and central nervous system (CNS) receptor pharmacology to discover and develop new therapies.

We seek to transform the lives of people suffering from neuroscience diseases, including Parkinson’s disease, epilepsy and schizophrenia, through the development of novel therapies. We have built a highly experienced team of senior leaders and neuroscience drug developers who combine a nimble, results-driven biotech mindset with the proven expertise of pharmaceutical company drug discovery and development.

Crossject, publicly traded on the Paris exchange, has developed a proprietary, needle free auto-injector (ZENEO®) which enables the intuitive intramuscular or subcutaneous administration of pre-filled injectable drugs in less than 1/10th of a second, in only two steps (open, push on the injection site).
Crossject will commercialize, its proprietary, clinically proven needle free auto-injector through partners, a portfolio of rescue drug-device combinations, for example Epinephrine in anaphylactic shock, Midazolam in epileptic seizure, Terbutaline in severe asthma exacerbation, or Hydrocortisone in adrenal crisis.
Our innovative needle-free drug delivery based portfolio could be a great fit with your emergency care positioning. I would like to introduce you to the ZENEO® key benefits and learn more about your in-licensing strategy and how we might work together.

FEBICO's current major development of new drug focuses on the treatment of global emerging infectious diseases and hepatitis-related diseases.

1.  Influenza

FEBICO’s Apomivir obtained the approval of US (IND120123) and Taiwan INDs application in 2013 and 2014, respectively. In previous experiments, FB-1603, the active pharmaceutical ingredient of Apomivir, was found to inhibit a variety of viruses in cellular experiments, including influenza A/H1N1, A/H3N2, influenza B, novel influenza viruses (2009), and influenza viruses resistant to tamiflu. Animal experiments have shown oral administration of FB-1603 can effectively reduce the mortality rate of mice caused by influenza A. Apomivir® is designed as oral capsule and given to patients infected with influenza within 48 hours of confirmed infection. The primary outcome measures the time reaching afebrile compared to the control group.

2. COVID-19 (SARs-CoV-2)

The new coronavirus hit the world in 2020, causing tens of millions infections and millions of deaths. In addition to the typical clinical pathology includes respiratory symptoms, severe patients will progress to severe pneumonia, acute respiratory distress syndrome (ARDS) or multiple organ failure, shock or even death. Therefore, the threat is quite big.FB-1603 has been proven in cellular and animal experiments to effectively reduce inflammation and accelerate the healing of scarred tissues. It has also been found in cellular experiments to inhibit pulmonary fibrosis. Because FB-1603 is the active pharmaceutical ingredient of Apomivir. Previous IND 120123 documents and new cellular data against COVID-19 were used to file a pre-IND (151566).

3. Treat liver damage

Current available treatments for liver cancer include surgical resection, liver transplantation, local destruction therapy, transarterial chemoembolization (TACE), chemotherapy and targeted therapy. However, according to clinical literature statistics, about 10% of patients treated with surgical resection or TACE will have postoperative complications such as deterioration of liver function (increased AST/ALT), jaundice, liver failure, and leads to 5% mortality rate. However, there are no effective preventive measures or therapeutic drugs to reduce the incidence of postoperative liver injury. In early phase of clinical trials, it has been observed that FB-1603 help the improvement of patients' liver function after hepatectomy or chemoembolization therapy.

4. Treat Herpes Virus

Herpes virus is a common infectious virus. Depending on the type of virus, it can cause redness and swelling of the skin on the lips or external genitals, resulting in blisters and ulcers, causing stinging and discomfort. Once infected with the herpes virus, the virus will be permanently latent in the human ganglion, and will repeatedly attack when the immune system is weakened. FB1706 has been proven in cellular study to effectively inhibit herpes type 1 and type 2 viruses with a very low dose, and some data show that topical application can shorten the course of the individual’s disease and accelerate the recovery time. The animal module for the herpes virus is currently under establishment. We expect to complete the animal studies before June 2021 and complete documentation of toxicology study and CMC (Chemistry, manufacturing, and control) report.

5. Liver fibrosis treatment

In the past, liver disease was considered a national disease in Asian community. So far, about 10,000 people in Taiwan are diagnosed with liver cancer and 7,700 people die from liver cancer every year. It still ranks as third in cancer incidence and second in mortality. Therefore, chronic liver disease cannot be underestimated. A familiar trilogy is liver inflammation, cirrhosis, and finally liver cancer.

The major cause is that when liver cells are damaged for a long time, liver tissue is formed into fibrosis, leads to hardening of liver, i.e. cirrhosis. Therefore, the key to treatment is to slow down the formation of fibrosis. Currently there is no approved drug to treat liver fibrosis in the world. FB-1807 has been observed in early phase of clinical trials to effectively reduce the liver fibrosis index of liver cancer patients. Preclinical study includes identification of active ingredient and animal studies are currently underway.

 6. Cure Hepatitis B

Chronic hepatitis B virus (HBV) infection is still an important issue of global health, causing nearly one million people die every year from major complications of liver cirrhosis and liver cancer. In recent years, the natural history of HBV and the replication mechanism have been clearly studied. Therefore, it is very important to know how to completely eliminate the virus to prevent viral infection. Although many different drugs have been developed to treat HBV, the long-term use of existing drugs is a heavy burden but still cannot achieve a complete cure. Therefore, a new generation of anti-viral medication is still needed.

FB-1808 has been observed in early clinical trials with significant anti-virus effects. We have confirmed the active ingredient and mechanism study is still ongoing.

At FJS Biopharmaceutical Inc., we combine technological innovation with world class process excellence. These enable our customers to deliver their discoveries. In our extensive contract development services portfolio we use advanced technologies to quickly and efficiently deliver products such as monoclonal antibodies, complex proteins and recombinant proteins.

Changes in the global marketplace are quickly altering the demands on biopharmaceutical manufacturing facilities. we have changed to Continuous Manufacturing Processes design that is cost-effective, flexible and responsive to a diversified product line. Continuous manufacturing processes offers a number of advantages:
1. More agile and flexible, and can therefore respond more rapidly to changes in supply or demand.
2. Reducing or eliminating scale-up bottlenecks could also help to accelerate the path to market for breakthrough
pharmaceuticals.
3. More efficient, reliable and cost-effective than traditional batch methods, resulting in significant cost savings down the line.
4. Producing smaller environmental footprint and reduce the risk of product quality failures compared to batch systems.
5. Supports a systematic, scientific and risk-based approach to pharmaceutical development. Development of a robust
process relies on utilizing the acquired product and process understanding to identify sources of variation to product quality
and to design appropriate control strategies to address these risk areas.
6. provides an opportunity to utilize this enhanced product and process understanding to adopt advanced manufacturing
controls and to produce uniformly high-quality products with reduced waste resulting from the generation of out-of-
specification material.

We are a preferred global partner to the Biopharmaceutical, biotech and specialty ingredients markets. Our solutions improve life quality by preventing illness, enabling healthier lifestyles and supporting a safe environment.

Global Clinical Trials (GCT) is a premium contract-research organization (CRO) that offers support for the clinical Phase I-IV studies as well as post-marketing activities to Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions. Headquartered in Princeton, USA, GCT offers both local and global support through 10 own operational offices in Bulgaria, Czech Republic, Georgia, Hungary, India, Kazakhstan, Latvia, Lithuania, Estonia, Moldova, Poland, Romania, Russia, Slovakia, Ukraine.
GCT team, that now consists of over 100 full-time clinical research professionals, gives individualized attention to each project and provides full range of services following the latest GCP, EMA and FDA guidelines at every stage of product development path. Our monitors and project managers are all certified clinicians experienced in GCP clinical research. Our experience, competent staff, close contact with the KOLs and the immense enrollment potential of the covered region ensure fast study start-up and compliance with the set timelines.
GCT owns 400 sq.m. (4300 ft2) Drug Storage and Distribution facility in St. Petersburg, Russia. It is fully equipped, disaster protected and has multiple modes of storage (ambient, climate controlled, refrigerated, frozen). High standards of work and client satisfaction are proved by the fact that more than 80% of the business come from repeat clients.
Since 2006 GCT is also an Exclusive Partner of “The White Nights” International ophthalmology congress in Russia.

When your clinical trial has to Overachieve in Central and Eastern Europe, HungaroTrial is here to help. Providing services for Phase 1 through Phase 4 clinical trials in Hungary, Czech Republic, Slovakia, Romania, Serbia, Croatia, Bulgaria, Bosnia, Poland, Ukraine, Belgium and Russia, HungaroTrial is the CEE region’s leading independent CRO.

To Overachieve, your clinical trial needs the best minds from beginning to end. That’s why Hungarotrial’s full-time staff includes 12 MDs of various specialties,more than any other independent CRO in the region. And you can be assured that our experienced team has built strong relationships with the most respected Key Opinion Leaders in CEE.

Our staff’s broad medical experience means that your clinical study benefits from diverse skills and synergistic teamwork. Over the past 18 years, HungaroTrial has become well known not just for this broad expertise, but also for our deep experience in Oncology, Rheumatology, Cardiovascular diseases, PAO, CNS and some other focus therapeutic areas.

iX Biopharma is established in 2008, and listed on Singapore Stock Exchange (Catalist Board) in 2015. iX is a specialist in novel wafer formulations using patented sublingual delivery technology, WaferiXTM , which is patented in China to 2033. R&D and manufacturing at wholly-owned GMP licensed facility in Melbourne, Australia.