About Globaxa
Scientific and regulatory consulting, built on clear reasoning
Globaxa Pharma Consultancy helps pharmaceutical, cosmetic and consumer-product companies meet safety and regulatory requirements — from toxicological assessments to country-specific registration dossiers.
Who we are
One team across science and regulation
Globaxa is based in Hyderabad, India. We combine disciplines that are often handled by separate providers: toxicology and health-based exposure limits, impurity and genotoxicity assessment, GMP auditing, regulatory documentation, cosmetic safety and pharmacovigilance.
Bringing these together matters because regulatory questions rarely stay in one box. A nitrosamine finding affects the dossier; a new supplier affects cleaning limits; a labelling change affects safety documentation. We look at the whole picture and explain it clearly.
We are an independent consultancy — not a regulator, notified body or certification body. Our role is to prepare, review and coordinate; decisions and submissions remain with you and the authorities.
Mission
Why we exist
To turn complex scientific and regulatory requirements into clear, defensible documentation and practical routes to market.
Vision
Where we are heading
To be a trusted partner for companies navigating the regulatory landscape — empowering innovation and driving sustainable growth.
Working principles
How we approach scientific and regulatory work
Evidence first
Conclusions follow from data and current guidance, with sources cited.
Show the reasoning
Every assumption and adjustment factor is written down so reviewers can follow it.
Region-specific
Requirements are confirmed for each market rather than assumed.
Clear roles
We say what we prepare, review and coordinate — and what stays with you or your partners.
Confidentiality
NDAs before data are shared, and information used only for your project.
Proportionate advice
Recommendations sized to the risk — not every legacy document needs rewriting.
Expertise
Six disciplines, one connected team
Regulatory questions rarely stay in one discipline. Our teams work together on the whole picture.
Toxicology
Health-based exposure limits, impurity qualification and safety assessments.
Impurity science
Impurity profiling, (Q)SAR, ICH M7 and nitrosamine evaluation.
Quality and GMP
Supplier audits, gap assessments and inspection readiness.
Regulatory affairs
CTD/ACTD dossiers, DMFs, labelling, queries and lifecycle.
Cosmetic safety
Safety reports, product information files and compliance.
Pharmacovigilance
Case processing, safety reporting and PV systems.
How we work
A clear sequence for every engagement
We agree the scope, responsibilities and deliverables before work starts, and keep you informed throughout.
- Understand the requirementYour product, target market, deadline and the question you need answered.
- Assess what existsThe product, the market rules and the documentation you already have.
- Identify the gapsThe applicable requirements and where your data or documents fall short.
- Define scope and deliverablesA written proposal with deliverables, responsibilities and timing.
- Do the workScientific or regulatory deliverables, reviewed before they reach you.
- Support what comes nextQueries, updates and lifecycle needs, where agreed.
FAQs
About Globaxa: frequently asked questions
Where is Globaxa based?
Our office is in Kanchanbagh, Hyderabad, Telangana, India. Contact details are on the Contact Us page.
Is Globaxa a regulator or certification body?
No. We are an independent consultancy. We do not grant approvals, certificates or licences.
Do you run laboratory studies?
No. Studies such as stability, E&L, Ames or bioequivalence are performed by laboratories and CROs that you appoint. We help define what is needed and assess the results.
Can you sign an NDA before we share information?
Yes, and we recommend it before any confidential formulas, processes or data are exchanged.
Talk to our team
Tell us what you are working on. We will help you identify the right next step.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST