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Capability

regulatory operations

Suppliers
2
States & provinces
2
Countries
1

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

Suppliers

Biologics Consulting is an FDA regulatory affairs and product development consulting firm founded in 1993 by former FDA officers as a fully employee-owned (ESOP) company. It provides integrated multidisciplinary regulatory strategy and operations support for biologics, pharmaceuticals, medical devices, and combination products, with 30+ years of history, 4700+ projects, and clients in 58+ countries.

biostatistics consultationclinical developmentCMCFDA meeting preparationFDA submissionsnonclinical pharmacology/toxicologyquality systems & trainingregulatory strategyStaff augmentation

CONNEXUS TECHNOLOGY, LLC

PHILADELPHIA, PA

Connexus Technology delivers data-driven Digital Transformation solutions and Business IT Staff Augmentation services, with a specialized focus on Enterprise Data Management and IT Infrastructure. The company provides experienced professionals in Project Management, Business Analysis, Product Ownership, and Change Management, and offers Life Science solutions supporting clinical research, clinical data management, regulatory operations, and pharma development. It has served organizations across industries for over 22 years.

application developmentclinical data managementdata integrationdata transformationDigital transformationenterprise data managementERP implementationinformation securityIT infrastructureIT project managementIT staff augmentationLegacy system modernization

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