Markets We Serve

Axentra supports pharmaceutical, biologics, and nutraceutical companies across a wide range of regulated markets. Our experience spans multiple agencies, product categories, and development pathways.

Geographic Regulatory Markets

We provide regulatory and compliance support for submissions, registration, and GMP readiness across:

U.S. FDA – Drugs, APIs, OTCs, combination products
European Union (EMA + National Agencies)
United Kingdom (MHRA)
Australia (TGA)
Canada (Health Canada)
PIC/S Member Countries including Singapore, Switzerland, and others

Our global perspective helps clients build harmonized strategies aligned with ICH, USP, Ph. Eur., and regional requirements.

Product & Dosage Form Expertise

We work across a broad range of finished dosage forms including:

Oral Solid Dosage (tablets, capsules)
Oral Liquids, Syrups, Suspensions
Sterile Injectables (vials, ampoules, PFS)
Ophthalmic Preparations
Topicals & Transdermals
Inhalation products
APIs & intermediates
Nutraceuticals, herbal supplements, and dietary supplements

Client Categories We Serve

Axentra provides specialized support for:

Pharmaceutical manufacturers
Contract Manufacturing Organizations (CMOs/CDMOs)
Analytical and QC laboratories
Nutraceutical and dietary supplement manufacturers
U.S. importers and distributors
Regulatory affairs consultants & boutique agencies seeking a U.S. operational partner
Start-ups and early-stage innovators seeking regulatory pathways

CDMOs & Technology Transfer Partners

We collaborate with Contract Development and Manufacturing Organizations (CDMOs) and sponsor companies to ensure compliant partnerships.Through our affiliate, Nirnaya Pharma Management Services LLP (India), we perform technical due diligence, quality audits, and facility assessments—ensuring CDMOs meet FDA, EMA, and WHO-GMP expectations before engagement.