top of page

Chemistry, Manufacturing, & Controls

GLOBAL offers the highest quality services in complex biologics, biosimilars, drugs, generics, & combination products. 

Regulatory Consulting and Technical Writing

Our world-class scientists and regulatory experts can guide your product from inception to bedside and through the many technical and regulatory development hurdles along the way. We apply our knowledge of health authority requirements, technical acumen, and industry best practices to prepare technical and regulatory documents that are fit for purpose, scientifically sound, and aligned with agency requirements. Please see our most common services below and reach out to explore how we can best support your team!

Technical Services

  • GxP documentation (for example, batch records, SOPs, protocols, reports)

  • Deviation investigations

  • Compliance gap assessment

  • Strategic review of development plans

  • Pre-approval inspections and readiness

  • Comparability studies

  • Commercial control strategies

  • Risk assessments

  • PPQ and CPV master plans, protocols,

       and reports

Regulatory Services

  • IND, IMPD, and clinical trial applications

  • License applications: BLA, NDA, MAA

  • DSURs, annual reports

  • DMFs

  • Post-approval supplements

  • DEA Quota requests

  • Agency meeting requests, briefing books, and interactions

  • Responses to agency information requests,clinical holds, and complete response letters

  • Change control assessments

  • RLD and IIG excipient reviews

  • Due diligence and gap analyses

  • Controlled correspondence

  • Regulatory advocacy and policy

  • Orphan Drug and Breakthrough Therapy applications

We Support a Wide Range of Products

Small Molecule.png
Biologics & Biosimilars
Drugs & Biologics.png
Drugs & Generics
Combination Products.png
Combination Products

Additional Services and Offerings



eCTD Publishing.jpg

eCTD Publishing & Submission Management


Medical Writing Solutions

Meet the CMC Leadership Team

Tracy Janus.jpg

Tracy Janus, MSC

Sr VP, Regulatory Affairs & CMC

  • Grey LinkedIn Icon

Location: Bucks County, PA

Favorite Biotech or Med Device Nerd Topic: Gene therapy

Biggest Thrill/Adventure Completed: My first Ragnar Trail Relay event

Most Important Bucket List Item: See the Northern Lights

Nashville Head Shot 1 (2).jpg

Doug Kremer, PhD

Director, CMC

  • Grey LinkedIn Icon

Location: Chapel Hill, NC

Favorite Biotech or Med Device Nerd Topic: Lyophilization

Biggest Thrill/Adventure

completed: Playing golf at Pebble Beach with my Dad

Most Important Bucket List Item: Learn to play the guitar

bottom of page