# Globaxa Pharma Consultancy

> Toxicology, regulatory, audit, cosmetic compliance and pharmacovigilance consulting for pharmaceutical and consumer-product businesses.


## Pages

- [Home](https://globaxa.in/): Toxicology, regulatory, audit, cosmetic compliance and pharmacovigilance consulting for pharmaceutical and consumer-product businesses.
- [Pharmacovigilance Process & System Support](https://globaxa.in/services/pharmacovigilance-process-system-support/): Design, set-up and improvement of PV systems: workflows, literature monitoring, training, audits and inspection readiness.
- [Safety Documentation & Regulatory Compliance](https://globaxa.in/services/safety-documentation-regulatory-compliance/): PSMF, risk management plans, PV SOPs and safety data exchange agreements that keep your pharmacovigilance system compliant and inspection-ready.
- [Adverse Event Assessment & Reporting](https://globaxa.in/services/adverse-event-assessment-reporting/): Medical and scientific assessment of adverse events, expedited reporting and periodic aggregate reports such as PSURs and PBRERs.
- [Drug Safety & Case Management Support](https://globaxa.in/services/drug-safety-case-management/): Case intake, triage, data entry, MedDRA coding, narratives, quality review and submission support for individual case safety reports.
- [Pharmacovigilance Services](https://globaxa.in/services/pharmacovigilance-services/): Flexible pharmacovigilance support — from individual activities to end-to-end operations — for marketing authorisation holders and exporters.
- [Pharmacovigilance](https://globaxa.in/services/pharmacovigilance/): Case processing, adverse event assessment and reporting, aggregate reports, PV documentation and pharmacovigilance system support.
- [Safety & Regulatory Documentation Support](https://globaxa.in/services/safety-regulatory-documentation-support/): Safety data sheets, ingredient toxicological profiles, hazard classification and safety statements for cosmetic and consumer products.
- [Cosmetic & Consumer Product Regulatory Compliance](https://globaxa.in/services/cosmetic-consumer-regulatory-compliance/): Ingredient, labelling, claims and notification compliance for cosmetics and consumer products in each target market.
- [Product Information File (PIF) Preparation & Review](https://globaxa.in/services/product-information-file-pif/): Complete product information files for cosmetics under EU, UK and ASEAN requirements, ready for authority inspection.
- [Cosmetic Product Safety Reports (CPSR)](https://globaxa.in/services/cosmetic-product-safety-reports-cpsr/): EU- and UK-format cosmetic product safety reports: ingredient toxicology, exposure, margin of safety and the safety assessor’s conclusion.
- [Cosmetic & Consumer Product Compliance](https://globaxa.in/services/cosmetic-consumer-product-compliance/): Cosmetic product safety reports, product information files, ingredient and label compliance, and safety documentation for consumer products.
- [Regulatory Submission Support](https://globaxa.in/services/regulatory-submission-support/): Submission planning, publishing, tracking, variations, renewals and re-registrations across your target markets.
- [Regulatory Deficiency & Query Handling](https://globaxa.in/services/regulatory-deficiency-query-handling/): Structured, evidence-based responses to deficiency letters and authority queries, coordinated across your technical teams.
- [Label, Artwork & Translation Compliance](https://globaxa.in/services/label-artwork-translation-compliance/): Market-specific review of labels, cartons, leaflets and artwork — including translations — against regulatory requirements.
- [API Documentation & DMF Support](https://globaxa.in/services/api-documentation-dmf-support/): Drug master files, ASMFs, open and restricted parts and API technical packages for finished-product applicants.
- [CTD & ACTD Dossier Preparation](https://globaxa.in/services/ctd-actd-dossier-preparation/): Dossiers compiled in ICH CTD or ASEAN ACTD format, adapted to each target market’s regional requirements.
- [Regulatory Services](https://globaxa.in/services/regulatory-services/): CTD and ACTD dossiers, API documentation and DMFs, label and artwork compliance, deficiency responses and submission support.
- [Inspection Readiness & Preparation](https://globaxa.in/services/inspection-readiness-preparation/): Mock inspections, storyboards, front- and back-room set-up and team coaching ahead of regulatory or customer inspections.
- [Regulatory Audit Response Support](https://globaxa.in/services/regulatory-audit-response-support/): Clear, evidenced responses to inspection observations and audit findings, with realistic CAPA plans and follow-up.
- [Regulatory Gap Analysis](https://globaxa.in/services/regulatory-gap-analysis/): Assess dossiers, DMFs and technical documentation against a target market’s requirements before you submit.
- [Cause-Based Audits](https://globaxa.in/services/cause-based-audits/): Independent for-cause audits after serious deviations, complaints, recalls, data-integrity concerns or repeated failures.
- [Gap Assessments](https://globaxa.in/services/gap-assessments/): Site and quality-system assessments against WHO GMP, EU GMP, PIC/S, US FDA or Revised Schedule M, with a prioritised remediation plan.
- [Supplier Audits](https://globaxa.in/services/supplier-audits/): GMP audits of API, excipient, packaging and service suppliers to support qualification and ongoing supplier management.
- [Supplier Audits, Gap Assessments & Regulatory Audit Support](https://globaxa.in/services/supplier-audits-gap-assessments/): Supplier and for-cause audits, GMP and regulatory gap assessments, inspection readiness and support with inspection responses.
- [Genotoxicity Risk Assessment & Evaluation](https://globaxa.in/services/genotoxicity-risk-assessment-evaluation/): End-to-end ICH M7 assessments: classification, acceptable intakes, nitrosamine (CPCA) evaluation and control strategies ready for submission.
- [Toxicological Risk Assessments](https://globaxa.in/services/toxicological-risk-assessments/): Toxicological qualification of non-mutagenic impurities, degradants, residual solvents, elemental impurities and leachables — plus safety evaluations for regulatory queries.
- [Extractables & Leachables (E&L) Assessment](https://globaxa.in/services/extractables-leachables-assessment/): Study design input, analytical-threshold setting and toxicological safety assessment of extractables and leachables from packaging, devices and process equipment.
- [In Silico QSAR Assessment](https://globaxa.in/services/in-silico-qsar-assessment/): Two complementary (Q)SAR predictions per structure with documented expert review, as required by ICH M7.
- [Advanced Impurity Profiling](https://globaxa.in/services/advanced-impurity-profiling/): Systematic identification of actual and potential impurities from the synthetic route, reagents and degradation — the starting point for ICH M7 and Q3A/Q3B.
- [Genotoxicity Risk Assessment of Impurities](https://globaxa.in/services/genotoxicity-risk-assessment-impurities/): ICH M7 assessments, in silico (Q)SAR, impurity profiling, nitrosamine evaluation, extractables and leachables, and impurity qualification.
- [Toxicological Risk Assessment Reports](https://globaxa.in/services/toxicological-risk-assessment-reports/): Toxicological assessments for cleaning agents, intermediates, degradation products and cross-contamination events in shared facilities.
- [Cleaning Validation Protocol Development & Support](https://globaxa.in/services/cleaning-validation-protocol-support/): Protocols, sampling plans, acceptance criteria, reports and deviation support for cleaning validation studies.
- [OEB Assessment & Banding](https://globaxa.in/services/oeb-assessment-banding/): Hazard-based banding for APIs and intermediates with limited data, linked to practical handling and containment requirements.
- [OEL Determination & Exposure Assessment](https://globaxa.in/services/oel-determination-exposure-assessment/): Occupational exposure limits for APIs and potent compounds, compared with expected or measured exposure to guide containment decisions.
- [ADE/PDE/OEL Calculation Services](https://globaxa.in/services/ade-pde-oel-calculation/): Signed health-based exposure limit monographs — PDE/ADE for cleaning validation and OEL for worker protection — with a transparent rationale.
- [Comprehensive Cleaning Validation Services](https://globaxa.in/services/comprehensive-cleaning-validation/): Programme-level support: HBEL-based limits, product grouping, worst-case selection and a lifecycle approach to cleaning validation.
- [Expert ADE/PDE, OEL & Cleaning Validation Solutions](https://globaxa.in/services/ade-pde-oel-cleaning-validation/): Health-based exposure limits, occupational limits and cleaning validation support for shared pharmaceutical facilities.
- [Image credits](https://globaxa.in/image-credits/): Sources and licences for photographs used on this website.
- [Disclaimer](https://globaxa.in/disclaimer/): Important information about the scope of Globaxa’s services and the information on this website.
- [Terms and Conditions](https://globaxa.in/terms-and-conditions/): Terms governing the use of the Globaxa Pharma Consultancy website.
- [Contact Us](https://globaxa.in/contact-us/): Request a consultation, or contact our team by phone or email.
- [Blogs](https://globaxa.in/blogs/): Practical, referenced explainers on toxicology, impurities, regulatory dossiers, GMP inspections and cosmetic safety.
- [Services](https://globaxa.in/services/): Six service areas and 31 defined services, from health-based exposure limits to pharmacovigilance.
- [About Us](https://globaxa.in/about-us/): A Hyderabad-based consultancy combining toxicology, regulatory affairs, audits, cosmetic safety and pharmacovigilance.
- [Privacy Policy](https://globaxa.in/privacy-policy/): How Globaxa Pharma Consultancy collects, uses and protects personal data submitted through this website, including enquiries and cookies.


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