Clinlogix

- Consulting company specializing in highly strategic drug-development advice and services for our partners in the pharmaceutical and healthcare industry
- Recognized insightful leaders who seek and create opportunities throughout the product life cycle to ensure each client’s asset is successfully transformed into a valuable therapy for patients
- Experienced team that successfully navigates across therapeutic areas, interacting with FDA divisions and building global development programs
- Collaborates with clients to provide embedded or virtual solutions by integrating seamlessly into product teams and advising senior management
- Also provides medical writing and submission services: Medical and scientific writing experts author a broad range of clinical and non-clinical documents and publications needed throughout a product’s development and for global regulatory submissions
- Operations and submissions experts have an approved FDA gateway and use validated eCTD software to perform client IND, NDA/BLA and pharmacovigilance to the FDA.

For a vast array of therapeutic categories, we provide:
- Strategic pharmaceutical analysis and brainstorming, including clinical and regulatory development
- Regulatory evaluations – expert data analysis, review and reporting
- Regulatory and medical due-diligence reviews, including evaluating data for licensing candidates
- Safety data analysis – drugs, devices and biologics
- Regulatory intelligence, including data assessment for “what-if” scenarios
- Clinical development planning and trial design.

Services Provided:
- Briefing packages:
from pre-IND to pre-NDA (drugs)
from pre-IDE to pre-PMA or 510k (devices)
- INTERACT Program, pre-BLA (biologics)
- IND preparation
- Preparation of regulatory applications in eCTD standard, including NDAs, 510ks, PMAs & BLAs
- Strategic documents for internal decision-making, including white papers
- New-product and marketing-materials evaluations
-Report writing for all clinical-trial phases

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

This channel is intended only for US and Canadian visitors. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada. An unaffiliated and unrelated company, Merck & Co. holds the rights in the trademark MERCK in the US and Canada.

Bringing pharma and biopharma healthcare solutions to life is complex, requiring specialist knowledge and expertise at every step.

This is why MilliporeSigma offers the BioReliance® portfolio – an offering of exceptional, risk-mitigating approaches, testing, critical services and customized, complete solutions to help you bring life-changing drugs to market, faster. We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. With locations worldwide, we offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. For more information, visit www.bioreliance.com.

This channel is intended only for US and Canadian visitors. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada. An unaffiliated and unrelated company, Merck & Co. holds the rights in the trademark MERCK in the US and Canada.

Bringing pharma and biopharma healthcare solutions to life is complex, requiring specialist knowledge and expertise at every step.

This is why MilliporeSigma offers the BioReliance® portfolio – an offering of exceptional, risk-mitigating approaches, testing, critical services and customized, complete solutions to help you bring life-changing drugs to market, faster. We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. With locations worldwide, we offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. For more information, visit www.bioreliance.com.

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

With over 40 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.

Our operations are strategically located in:
Lincoln, Nebraska (Corporate Headquarters)
Philadelphia, Pennsylvania
Phoenix, Arizona
Belfast, Northern Ireland,UK
Zurich, Switzerland
Richmond, Virginia
Montreal, Quebec, Canada

For more information, visit: www.celerion.com