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Capability

FDA meetings

Suppliers
2
States & provinces
1
Countries
1

2 fda meetings suppliers across 1 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

AOTEK, LLC

FREDERICK, MD

AOTEK LLC is a provider of innovative solutions for the federal government and the private sector in the areas of health, science, and technology. It is a trusted partner of federal prime contractors and provides integrated health mission systems and information services support to the Department of Defense (DoD) and Defense Health Agency (DHA). AOTEK LLC is an SBA-certified Women Owned Small Business (WOSB) and Economically Disadvantaged Women Owned Small Business. AOTEK stands for Alpha and Omega Technologies.

Acquisition Support ServicesBiostatistics and Data ManagementcGMP/GCP/GLP TrainingClinical Trials Monitoring Supportcommunications and public relationsfeasibility studiesFinancial/Budget AssistanceMedical Writing and Documentationperformance metrics and evaluationpolicy developmentProject Management IAW PMBOKquality assurance/quality controlRegulatory Affairsregulatory strategyResearch Protocol Designrisk managementstakeholder engagementstrategic-planningtelehealth solutions

Compiled from public sources

FAST-TRACK DRUGS & BIOLOGICS LLC

POOLESVILLE, MD

Fast-Track Drugs and Biologics, LLC is a contract research organization (CRO) providing strategic planning, clinical trial and regulatory support services to the pharmaceutical and biotech industries for the development and licensure of vaccines and therapeutics for human diseases. It uses a critical path planning approach to move products through the regulatory process with the shortest timeline to product licensure.

BLA preparationclinical protocol writingclinical trial supportdata statistical analysiselectronic data captureenrollment and randomizationGLP auditsIND preparationIRB approval assistanceNDA preparationquality assuranceregulatory supportstrategic-planning

Compiled from public sources

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