Services & expertise
GMP and quality systems, regulatory affairs, validation, data integrity, audits and inspection readiness — practical support across the product lifecycle.
Integrated pharmaceutical consulting services.
One expert network supporting quality, regulatory, validation, technical operations and commercial expansion — from a single audit to a full local presence.
GxP & Quality Compliance
EU GMP, PQS/QMS, SOPs, deviations, CAPA, change control, OOS/OOT, QRM, supplier qualification and data integrity.
Request support →Regulatory Affairs & CTD
EU strategy, MAA pathways, CTD/eCTD review and preparation, CMC, variations, renewals and authority responses.
Review my dossier →Validation & Qualification
VMP, URS, DQ/IQ/OQ/PQ, process and packaging validation, hold-time studies and lifecycle validation.
Plan validation →Cleaning Validation & HBEL
PDE/ADE/HBEL strategy, MACO, worst-case selection, sampling, recovery and legacy remediation.
Assess my program →Audits & Inspection Readiness
GMP/GDP audits, mock inspections, supplier and CMO audits, pre-inspection readiness and remediation.
Prepare for inspection →Digital GxP & Data Integrity
CSV/CSA, GAMP 5, Annex 11, 21 CFR Part 11, LIMS/MES/eQMS validation, audit trails and ALCOA+.
Assess digital compliance →Pharmaceutical Development
Formulation strategy, generic development, technology transfer, scale-up, stability and CMO/CDMO selection.
Discuss development →Licensing & Market Access
In-licensing, out-licensing, product sourcing, partner search, due diligence and EU–MENA market entry.
Explore an opportunity →Laboratory Excellence
QC systems, analytical validation and transfer, stability, instrument qualification and OOS/OOT.
Explore service →Facilities, Engineering & CQV
GMP facility design review, cleanrooms, HVAC, utilities, flows, commissioning and qualification.
Explore service →Pharmacovigilance
PV systems, PSMF/QPPV support, signal management, aggregate reports, audits and inspection readiness.
Explore service →Interim Experts
Experienced QA, validation, regulatory and GMP resources for temporary leadership and execution.
Explore service →Bioequivalence Studies
End-to-end BE study management for generics and hybrids — study design and biowaiver strategy, CRO and bioanalytical-laboratory selection and oversight, GCP-compliant conduct under the Clinical Trials Regulation, statistical analysis and integration into the CTD — to ICH M13A, the EMA bioequivalence guideline and BCS-based biowaiver (ICH M9) requirements.
Facing a compliance or regulatory challenge?
Urgent pharmaceutical compliance support when time matters.
For upcoming inspections, critical GMP observations, authority deficiencies, major deviations, data-integrity findings, supplier failures and dossier issues.
A single partner across the product lifecycle.
Most clients start at one stage and stay for the rest. The order is a real sequence — each stage sets up the next.
GxP & quality systems
Audits, gap analysis and quality-system remediation against EU GMP, GDP and data-integrity expectations.
Qualification & validation
Process, cleaning, computerized-system and facility validation across the full lifecycle.
Regulatory & CTD
EU strategy, CTD/eCTD preparation, MAA pathways, variations and authority responses.
Licensing & access
In- and out-licensing, partner search and market entry across EU, UK and MENA.
Bring your medicine to Europe, compliantly.
Tell us about your product and target markets — we’ll map the fastest compliant route to authorisation and supply.