Services
Scientific and regulatory services
Six connected service areas, each with clearly defined deliverables. Search for what you need, or browse by area.
Showing all 31 services
Expert ADE/PDE, OEL & Cleaning Validation Solutions
Health-based exposure limits, occupational limits and cleaning validation support for shared pharmaceutical facilities.
- Comprehensive Cleaning Validation ServicesProgramme-level support: HBEL-based limits, product grouping, worst-case selection and a lifecycle approach to cleaning validation.
- ADE/PDE/OEL Calculation ServicesSigned health-based exposure limit monographs — PDE/ADE for cleaning validation and OEL for worker protection — with a transparent rationale.
- OEL Determination & Exposure AssessmentOccupational exposure limits for APIs and potent compounds, compared with expected or measured exposure to guide containment decisions.
- OEB Assessment & BandingHazard-based banding for APIs and intermediates with limited data, linked to practical handling and containment requirements.
- Cleaning Validation Protocol Development & SupportProtocols, sampling plans, acceptance criteria, reports and deviation support for cleaning validation studies.
- Toxicological Risk Assessment ReportsToxicological assessments for cleaning agents, intermediates, degradation products and cross-contamination events in shared facilities.
Genotoxicity Risk Assessment of Impurities
ICH M7 assessments, in silico (Q)SAR, impurity profiling, nitrosamine evaluation, extractables and leachables, and impurity qualification.
- Advanced Impurity ProfilingSystematic identification of actual and potential impurities from the synthetic route, reagents and degradation — the starting point for ICH M7 and Q3A/Q3B.
- In Silico QSAR AssessmentTwo complementary (Q)SAR predictions per structure with documented expert review, as required by ICH M7.
- Extractables & Leachables (E&L) AssessmentStudy design input, analytical-threshold setting and toxicological safety assessment of extractables and leachables from packaging, devices and process equipment.
- Toxicological Risk AssessmentsToxicological qualification of non-mutagenic impurities, degradants, residual solvents, elemental impurities and leachables — plus safety evaluations for regulatory queries.
- Genotoxicity Risk Assessment & EvaluationEnd-to-end ICH M7 assessments: classification, acceptable intakes, nitrosamine (CPCA) evaluation and control strategies ready for submission.
Supplier Audits, Gap Assessments & Regulatory Audit Support
Supplier and for-cause audits, GMP and regulatory gap assessments, inspection readiness and support with inspection responses.
- Supplier AuditsGMP audits of API, excipient, packaging and service suppliers to support qualification and ongoing supplier management.
- Gap AssessmentsSite and quality-system assessments against WHO GMP, EU GMP, PIC/S, US FDA or Revised Schedule M, with a prioritised remediation plan.
- Cause-Based AuditsIndependent for-cause audits after serious deviations, complaints, recalls, data-integrity concerns or repeated failures.
- Regulatory Gap AnalysisAssess dossiers, DMFs and technical documentation against a target market’s requirements before you submit.
- Regulatory Audit Response SupportClear, evidenced responses to inspection observations and audit findings, with realistic CAPA plans and follow-up.
- Inspection Readiness & PreparationMock inspections, storyboards, front- and back-room set-up and team coaching ahead of regulatory or customer inspections.
Regulatory Services
CTD and ACTD dossiers, API documentation and DMFs, label and artwork compliance, deficiency responses and submission support.
- CTD & ACTD Dossier PreparationDossiers compiled in ICH CTD or ASEAN ACTD format, adapted to each target market’s regional requirements.
- API Documentation & DMF SupportDrug master files, ASMFs, open and restricted parts and API technical packages for finished-product applicants.
- Label, Artwork & Translation ComplianceMarket-specific review of labels, cartons, leaflets and artwork — including translations — against regulatory requirements.
- Regulatory Deficiency & Query HandlingStructured, evidence-based responses to deficiency letters and authority queries, coordinated across your technical teams.
- Regulatory Submission SupportSubmission planning, publishing, tracking, variations, renewals and re-registrations across your target markets.
Cosmetic & Consumer Product Compliance
Cosmetic product safety reports, product information files, ingredient and label compliance, and safety documentation for consumer products.
- 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.
- Product Information File (PIF) Preparation & ReviewComplete product information files for cosmetics under EU, UK and ASEAN requirements, ready for authority inspection.
- Cosmetic & Consumer Product Regulatory ComplianceIngredient, labelling, claims and notification compliance for cosmetics and consumer products in each target market.
- Safety & Regulatory Documentation SupportSafety data sheets, ingredient toxicological profiles, hazard classification and safety statements for cosmetic and consumer products.
Pharmacovigilance
Case processing, adverse event assessment and reporting, aggregate reports, PV documentation and pharmacovigilance system support.
- Pharmacovigilance ServicesFlexible pharmacovigilance support — from individual activities to end-to-end operations — for marketing authorisation holders and exporters.
- Drug Safety & Case Management SupportCase intake, triage, data entry, MedDRA coding, narratives, quality review and submission support for individual case safety reports.
- Adverse Event Assessment & ReportingMedical and scientific assessment of adverse events, expedited reporting and periodic aggregate reports such as PSURs and PBRERs.
- Safety Documentation & Regulatory CompliancePSMF, risk management plans, PV SOPs and safety data exchange agreements that keep your pharmacovigilance system compliant and inspection-ready.
- Pharmacovigilance Process & System SupportDesign, set-up and improvement of PV systems: workflows, literature monitoring, training, audits and inspection readiness.
No service matches that search. Try a broader term, or describe your requirement and we will point you to the right scope. Contact our team
How it works
Every service follows the same clear sequence
Whichever service you choose, you will know the scope, the deliverables and what we need from you before work begins.
- 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
Questions about our services
Can I combine services from different areas?
Yes. Many projects combine areas — for example an impurity assessment, a DMF update and a dossier response. We coordinate them as one engagement.
Can I buy a single assessment?
Yes. Most services can be commissioned as single deliverables or as part of ongoing support.
What if my requirement is not listed?
Describe it in the enquiry form. If it is outside our scope, we will tell you.
Not sure which service you need?
Describe your product and your question. We will recommend a scope — or tell you if it is outside ours.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
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+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST