ANP Technologies, Inc.

Italian multinational company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio mainly based on hyaluronic acid (HA) in joint care, advanced wound care, ophthalmology, aesthetic and autologous biological therapy. Over 55 years of R&D have placed Fidia at the forefront in the production of natural and functionalized HA, with different ranges of MW (1,100 patents). Manufacturing operations – located in Italy - are inspected and approved by major international health authorities, including the US and Korean FDA, the Brazilian ANVISA and G-MED Notified Body, and comply with the strictest international regulations and safety standards. Fidia extends its global reach through local partners in 100+ countries worldwide, as well as wholly-owned subsidiaries in USA, Germany, Austria, Spain, France, Russia, Czech Republic, Slovakia, Romania, Egypt and Middle East.

DRUG DELIVERY SOLUTIONS - DRUG PRODUCT DEVELOPMENT - LICENSING-OUT OPPORTUNITIES

Galenix provides a range of full R&D pharmaceutical services and Drug Delivery Solutions to health companies for fast access of their products on the market.

●●● From the sourcing of the API through the Drug Product development process, including preformulation, formulation, to clinical supplies, quality control, ICH stabilities and regulatory dossier submission for Europe and US FDA registration.

Galenix provides its customers drug products “ready to launch” holding a Marketing Authorization.

●●● Galenix Innovations includes 6 different innovative technology platforms focusing on drug delivery solutions for life cycle management, new chemical entities and Biologicals using conventional medicinal presentations or its own patented technologies.

« Patients are central to our approaches »

Galenix team is focusing to preserve and/or to increase market shares on products through differentiation in accordance with regulations.

Accutest, a global independent and internationally accredited Contract Research Organisation (“CRO”), with more than 20 years of experience and over 700+ employees in supporting the end-to-end services for global bio-pharmaceutical, biotech, medical device, nutraceutical and FMCG companies. Accutest is the market leader among independent CROs, with the highest quality standards and quick turnaround times. We have a strong regulatory track record and numerous accreditation/approvals from global regulatory agencies.

We offer services in 3 verticals:
1. Bio-availability and Bio-equivalence studies (BA/BE) -
2. Clinical Development Services (CDS)- Phase II - IV studies, Post marketing, Investigator initiated & stand alone services (medical writing, regulatory consultancy, clinical data management)
3. Biologics Services - Solutions for biosimilars, novel biologics and non-biological complex generics

Successfully cleared below inspections:
USFDA – 33 times (latest Nov, 2018)
WHO – 23 times (latest Jan, 2019)
DCGI- 20 times (latest Oct, 2016)
EMA – 8 times (latest Dec, 2017)

Blueclinical provides all the critical conditions necessary for the success of your research project. Blueclinical operates in three different areas:

• Blueclinical Phase I
Blueclinical Phase I conducts phase I studies in healthy subjects and early proof-of-concept studies in selected patient populations.

• Blueclinical R&D
Blueclinical R&D's mission is to fuel translation research by supporting Portuguese institutions and businesses, especially start-ups, in the development of their R&D projects with a view to the subsequent marketing.

• Blueclinical Clinical Research Partnership
Blueclinical CRP is a network of hospitals and primary care centers that serve approximately half (5 million people) of the Portuguese population. The full network operates under a common quality management system to deliver excellence in clinical research.
Blueclinical CRP is your right partner for your clinical trials or observational studies!
Blueclinical CRP is your right clinical partner for your Horizon 2020 project!

Clinlogix is a Global Clinical Research Service & Consulting Organization working to improve human quality of life by supporting innovation in the life science industry. Its full suite of clinical research services supports the regulatory and clinical development pathway of medical devices, pharmaceuticals, biologics and diagnostics from proof of concept/discovery, early feasibility/first-in-human, through pivotal and the post-marketing/safety surveillance of client products. The company delivers this global expertise by way of its regional office locations in the US - Spring House, Pennsylvania, Europe - Mainz, Germany, Latin America - Medellin, Colombia and Asia Pacific - Tokyo, Japan.