We are a global consultancy service provider for pharmaceuticals (human and veterinary) and medical devices. With over 18 years of experience working with diverse pharmaceutical companies and attending multiple audits, we offer our consultancy services in Pharmacovigilance (including EU QPPV services), Regulatory Affairs and Quality Assurance.
What do we do? We Support Pharma Companies & Life Science Professionals with our Solutions.
In an era of growing regulatory requirements, pharmaceutical companies and regulatory professionals are under more pressure than ever. From meeting evolving GxP requirements to ensuring product safety and managing global submissions, the regulatory burden is rising and internal teams sometimes need support in order to keep up.
That’s where we come in. We provide end-to-end regulatory, pharmacovigilance, and GxP compliance services designed to support your team, reduce risk, and speed up your time to market.
Regulatory Affairs Services
Helping you register faster, respond smarter, and grow globally.
We support both small teams and large pharma companies with:
- End‑to‑end Regulatory Affairs Services
- Accessing new markets by MAA Support & Lifecycle Management – Variations, renewals, line extensions
- CTD/eCTD Dossier Preparation – Authoring, compilation, publishing
- Global Regulatory Submissions – EMA, MHRA, FDA, GCC, TGA and more
- Regulatory Intelligence – Keep up with changing regulations in key markets
- Authority Interactions – Scientific advice meetings, deficiency responses
- Translations of Product Information – including Linguistic reviews and Quality (QA) checks
- Review of artwork and promotional material
- Regulatory support activities for medical devices, food supplements and cannabis-based products
Pharmacovigilance (PV) Services
Taking care of the safety, compliance and reputation.
Today’s pharmacovigilance challenges include rising reporting obligations, signal detection pressures, and inspection readiness. Our PV solutions are built to help your QPPV, safety officers, and PV teams focus on what matters.
We offer:
- End‑to‑end PV services including EU QPPV and deputy
- Individual Case Safety Reports (ICSR) processing
- Literature Monitoring & Signal Detection
- PSUR / DSUR / RMP Authoring & Submissions
- Local PV Compliance Support across the EU and international markets
- 24/7 Safety Support and Audits to ensure inspection readiness
GMP & GDP Compliance Support
Quality is non-negotiable. Let us help you stay inspection-ready.
Whether you’re manufacturing or distributing, you must comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. But with evolving guidelines, workforce turnover, and frequent audits, maintaining compliance is challenging.
We support:
- End‑to‑end GxP services
- EU GMP certification of your manufacturing site
- EU GDP certification of your distribution site
- GMP/GDP Gap Assessments & Audits
- QMS Development and SOP Writing
- Deviation, CAPA, and Risk Management Systems
- Supporting QPs with GMP Compliance activities
- Supporting RPs with GDP Compliance activities
Translations
We provide translation services for various languages such as: Maltese, French, Russian, Ukrainian, Belarusian, Kazakh and Moldovan.
Who Do We Help?
We work directly with:
- Regulatory Affairs Managers
- QPPVs and PV Associates
- Quality Assurance Teams
- QPs and RPs
- Company owners
- Business development personnel
- Pharma Startups & SMEs scaling to new markets
If you’re feeling overstretched or preparing for an inspection, we’re here to provide scalable, compliant, and cost-effective support.
Why Partner With Us?
- Global Regulatory Expertise – EU, MENA, LATAM, CIS, Asia-Pacific
- Fast, Flexible Service – Designed for growing teams under pressure
- Proven Track Record – Supporting generics, biologics, injectables, and OTC
- Collaborative Approach – We become part of your team
Ready to lighten your regulatory load?
Contact us today to learn how we can support your regulatory, pharmacovigilance, and GMP/GDP compliance needs.