Aspen Pharma Australia

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)

Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.

Sign-up to receive invites to webinars, training courses and the latest cutting-edge information on clinical trials: https://go.pardot.com/l/129231/2020-07-27/39ng9k

ANTAEA Group of Companies is one of the largest Regional Clinical Research Organizations (CROs), providing high quality support in Southeast Europe, North Africa, Middle East and the Gulf Area.

The Group provides professional, yet flexible solutions, supporting our Clients to maximize their Research resources, in a cost effective manner. ANTAEA is dedicated to Services of scientific quality, management expertise, precision and reliable technology.

The Group includes integrated, marketing consultation services in our portfolio, based on Market Research, which cover products throughout their life cycle.

Specialities: Feasibility Projects, Initial Submissions, Amendments and Notifications to ECs (local and central) and Regulatory Authorities, Clinical Trials Monitoring in several different phases, Contracts for Clinical Trials Management, Contracts for Clinical Trial Rescue Projects, Design and Development of Clinical Trials Projects, Investigator Initiated Projects, Regulatory & Registration Projects (National, MRP, Variations etc.), Statistical Projects, Contracts for Investigator Training, Contract for Regulatory Services Training, Contract for Site Audit

ANTAEA also provides experienced CRAs to the Pharmaceutical and Biotechnology Industries and to CROs, in all the countries where ANTAEA is operating. ANTAEA training on procedures and setting standards and our technical support, guarantee uniformity in quality and timely delivery of projects.

APCER Life Sciences provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.

We bring medicinal / scientific expertise through our healthcare professionals & physicians and address full pharmacovigilance requirements for North America, UK & Europe markets. Our clients benefit from our vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness.

Our focus towards Patient safety and Risk profile management makes us the preferred choice for pharma companies who are looking for pre /post marketing compliance & reporting solutions.

We have scalable operations across five global offices which house more than 750 employees: Princeton, NJ, USA; London, UK; Germany, Wan Chai, Hong Kong, New Delhi and Ahmedabad, India.

Appletree CI Group is an expert niche CRO/CSO and global regulatory affairs service provider with track records in ophthalmology and medical device investigations. We are present in 11 European countries and have over 30 permanent staff. By having an in-depth understanding of local cultures and customs, as well as experience with national regulations we are able to facilitate your clinical development and regulatory projects.

Contract services:
- Clinical trials phases I-IV
- site feasibility, evaluation and initiation
- monitoring services, close out
- submissions
- Medical writing
- Consulting
- Clinical trial authorizations Europe
- Marketing authorization applications
- Life cycle management, variations management
- Scientific advice