Toxicology · Regulatory · Audits · Pharmacovigilance
Navigate global pharma regulations with scientific confidence.
From toxicology assessments and regulatory documentation to dossier preparation and submission support, Globaxa helps pharmaceutical and consumer-product businesses work through complex requirements with greater clarity.
- Guideline-referenced methods (ICH, EMA, PIC/S, USP)
- Country-specific regulatory documentation
- Confidential by default — NDA on request
What do you need help with?
Choose an area to see the services, deliverables and the information we need from you.
Who we are
A scientific and regulatory partner for every step
Globaxa Pharma Consultancy is a Hyderabad-based consultancy that brings toxicology, impurity assessment, GMP auditing, regulatory affairs, cosmetic safety and pharmacovigilance together under one roof.
We help manufacturers, exporters and product owners prepare defensible scientific documentation and clear, country-specific routes to submission — with a particular focus on markets in Africa and Asia.
Checklist-driven. Region-specific. Submission-ready. Every engagement starts with the requirements of your target market and ends with documentation your team and reviewers can follow.
Six connected service areas
Toxicology, impurities, audits, regulatory, cosmetics and pharmacovigilance.
Guideline-referenced
Methods traceable to ICH, EMA, PIC/S, WHO and USP guidance.
Region-specific
Country checklists for markets in Africa and Asia, alongside ICH CTD.
Confidential
NDAs before data are shared; formulas and processes stay protected.
Core services
Six connected service areas
From health-based exposure limits to pharmacovigilance — each area has defined services, deliverables and a clear list of what we need from you.
Expert ADE/PDE, OEL & Cleaning Validation Solutions
Health-based exposure limits, occupational limits and cleaning validation support for shared pharmaceutical facilities.
Genotoxicity Risk Assessment of Impurities
ICH M7 assessments, in silico (Q)SAR, impurity profiling, nitrosamine evaluation, extractables and leachables, and impurity qualification.
Supplier Audits, Gap Assessments & Regulatory Audit Support
Supplier and for-cause audits, GMP and regulatory gap assessments, inspection readiness and support with inspection responses.
Regulatory Services
CTD and ACTD dossiers, API documentation and DMFs, label and artwork compliance, deficiency responses and submission support.
Cosmetic & Consumer Product Compliance
Cosmetic product safety reports, product information files, ingredient and label compliance, and safety documentation for consumer products.
Pharmacovigilance
Case processing, adverse event assessment and reporting, aggregate reports, PV documentation and pharmacovigilance system support.
Scientific capabilities
Where specialist expertise makes the difference
Four areas where a defensible scientific rationale matters most to reviewers and inspectors.
PDE/ADE and OEL for shared facilities
The challenge
Multi-product equipment needs cleaning limits that inspectors accept and patients can rely on.
Our role
Toxicologists derive PDE/ADE and OEL values with transparent, justified adjustment factors.
You receive
Signed HBEL monographs, MACO calculations and cleaning-validation strategy.
Genotoxic impurities and nitrosamines
The challenge
Trace mutagenic impurities and NDSRIs must be controlled to strict acceptable intakes.
Our role
(Q)SAR with expert review, ICH M7 classification and CPCA-based limits.
You receive
ICH M7 risk assessment, nitrosamine evaluation and control strategy.
Extractables and leachables
The challenge
Packaging, devices and single-use components can release chemicals into a product.
Our role
We set analytical thresholds, review study design and assess every compound above them.
You receive
Threshold memo and a toxicological safety assessment for the dossier.
CTD and ACTD dossiers
The challenge
Each market expects its own format, regional documents and supporting data.
Our role
We compile and check dossiers against country-specific checklists before submission.
You receive
CTD or ACTD dossier with a completeness checklist and gap list.
Why Globaxa
What working with us looks like
We would rather show our reasoning than make claims. These are the principles behind every engagement.
Scientific depth
Toxicologists and regulatory specialists who work from primary data and current guidance — and show their reasoning.
Structured documentation
Checklist-driven workflows, so every requirement can be traced from the data to the dossier.
Country-specific focus
Requirements confirmed for each target market, with particular experience of Africa and Asia.
Clear communication
Plain-language explanations, defined scopes and a named contact throughout the engagement.
Lifecycle support
Support that continues after submission: queries, variations, renewals and updates.
Risk-aware planning
Honest advice on gaps, uncertainties and options — never guarantees we cannot control.
How it works
From first question to final deliverable
Six steps, agreed with you at the start, so you always know what happens next.
- 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.
Regulatory coverage
Country-specific routes to market in Africa and Asia
We turn complex, country-specific regulations into clear, step-by-step pathways — helping manufacturers, exporters and marketers prepare complete, well-organised submissions and avoid preventable rejections and delays.
- Groundwork & complianceMarket-entry planning, manufacturer–importer agreements and GMP or site applications.
- Pre-registrationBrand-name checks, site readiness and dossier gap analysis.
- Registration & dossierCTD/ACTD dossiers, BE documentation, artwork compliance and query handling.
- Post-registrationLifecycle management, variations, renewals, re-registrations and audit readiness.
Our office is in Hyderabad, India. The map shows our regional focus, not offices; we confirm for each enquiry whether and how we can support a specific market.
Who we support
Industries and products
Wherever product safety and regulation meet — from active ingredients to finished consumer products.
Finished pharmaceuticals
Tablets, capsules, injectables and other dosage forms — from toxicology to registration.
APIs and intermediates
Impurity, genotoxicity and DMF support for drug-substance manufacturers.
Cosmetics and personal care
Safety reports, product information files and label compliance.
Packaging, devices and consumer products
E&L assessments, safety data sheets and consumer-product safety documentation.
FAQs
Frequently asked questions
Which service should I start with?
Start with your question: the product, the target market and what you need to achieve. Use the service finder above, or describe your requirement in the enquiry form and we will recommend a scope.
Can you support exports to other countries?
Yes. Much of our regulatory work supports manufacturers and exporters entering markets in Africa and Asia. Tell us your target countries and we will confirm what we can support for each.
What do I receive at the end of an engagement?
It depends on the service: for example a signed PDE/ADE monograph, an ICH M7 assessment, an audit report or a compiled dossier. Every service page lists its deliverables.
How long does a project take?
Timelines depend on the product, the jurisdiction, the regulatory pathway and how complete your documentation is. We give you a schedule after reviewing your information. Review and approval times are set by the authorities, so we never promise them.
Can you guarantee regulatory approval?
No consultant can. Approval decisions rest with the authority. We prepare clear, well-structured documentation and support you through queries, which gives your application the best chance of an efficient review.
Is my information kept confidential?
Yes. We can sign a non-disclosure agreement before you share formulas, processes or data, and we use your information only for your project.
Planning your next regulatory or market-entry step?
Tell us about your product, target market or scientific assessment requirement. Our team can help you identify the appropriate next steps.
- 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