Comprehensive Expertise to Navigate Regulatory Complexities

Lose the stress and anxiety as you venture into the unfamiliar. With GLOBAL, you can tackle regulatory pain points head on with confidence.

Medical Devices/IVDs

GLOBAL’s Medical Device and IVD Division is dedicated to supporting your regulatory and compliance needs with a comprehensive suite of services. Our expertise includes:

Medical and Regulatory Writing including CEP/CERs, PMCF & PMS Plans/Reports, PSURs, SSCPs, and Literature Reviews
Project Management including schedule creation and full-service project management of EU MDR Deliverables
Regulatory and Technical Consulting including CER Strategy, PMCF strategy, SOP review, and template review
Training including our regulatory writing internship program, CER Essentials Course, and custom training programs

Biologics

GLOBAL has rich industry experience to provide you with the highest quality medical, regulatory, and technical writing, strategies, and project management for your:

Monoclonal antibodies
Therapeutic proteins
Cell & gene therapies
DNA & mRNA products
Microbiome therapeutics
Vaccines
Lipid-nanoparticles

Small Molecules

While drug formulations and mechanisms of action change over time, submission data and documentation requirements remain unwavering. Our CMC, regulatory strategists, and project managers can help with your:

Antivirals
Antibody-drug conjugates
Synthetic hormones
Enzyme inhibitors
Receptor agonists/antagonists
Ion channel modulators

Combination Products

Whether you’re entering the market as a wearable delivery device or converting your vial into a pre-filled syringe, combination device documentation requirements are rigorous. We’re here to help tackle your:

Essential performance requirements
Human factors study documentation
Product control strategies
Design control matrices
Device & design history files