Regulatory Compliance and Consulting

ELIQUENT brings together former FDA, EMA, and PMDA reviewers who understand how agencies think, from early strategy through market approval and lifecycle management. Across 52 countries, ELIQUENT works at every point on the pathway: pipeline and designation strategy, CMC, clinical programs, submissions, la...

Vicky is an AI platform for legislation and compliance. It brings EU and national legislation together in one place and shows exactly which obligations apply to your business and what they require. Applicable requirements become an auditable compliance register, where your team can assign tasks and track p...

KronML Pharma is an AI-powered quality and compliance platform for pharmaceutical and life sciences organizations. Designed to help Quality and Regulatory teams move from reactive remediation to continuous inspection readiness, it supports the analysis of FDA Form 483 observations, regulatory precedents an...

Most organisations face Scope 3 emissions as their largest decarbonization challenge. For many manufacturing, pharmaceutical, and chemical organisations, Scope 3 emissions can account for up to 90% of their total footprint, placing value-chain emissions under increasing regulatory and stakeholder scrutiny....

Produce dossier-ready safety assessments in minutes. Specialist agents cover permitted daily exposure (PDE/ADE) monographs, occupational exposure limits (OEL), extractables and leachables risk assessments, nitrosamine risk evaluation and environmental risk assessment (ERA), each anchored to ICH, EMA, FDA a...

In the Life Science industry, robust processes and effective technology management are essential to ensure consistent product quality throughout the product lifecycle. S4BT provides comprehensive Manufacturing Science & Technology (MS&T) support, helping organizations manage, optimize, and validate...

BE BioSol provides integrated regulatory, quality and technical support throughout the product lifecycle—from early development and technology transfer through validation, regulatory submission and commercial manufacturing. Our cross-functional teams work closely with clients to establish clear development...

Positive Organizations builds the supplier ESG due diligence system that pharmaceutical procurement now requires, and that upstream regulation increasingly assumes.


Around 55 percent or more of pharmaceutical emissions and most human rights exposure sit with suppliers, and 69 percent of pharma l...

Access the world’s scientific knowledge and advance your research. Use a combination of powerful search tools in CAS SciFinder and chat conversationally with our agentic AI tool CAS Newton to uncover trusted information found in journals and patents across multiple disciplines quickly and easily, and ident...

PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client’s site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions effi...

Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary method...

Over 400 developed recipes, 
including over 30 medical devices in various classes and indications,
in 20 pharmaceutical forms - 
everything starts in the Gofarm's R&D Laboratory.



In Gofarm's R&D Laboratory our and our clients' ideas take real shapes...

The Rapid Decon Station (RDS) is the flexible and fast material transfer chamber for decontamination of goods and RTP transfer containers.

Features • Simultaneous beta container decontamination • Grade A storage compliant with Annex 1 • Integrated bio-decontamination system • Exchange...

A structure based check that works with proprietary and novel chemicals, or search via a chemical or common name. Upload thousands of chemicals in a single check to see if they are potentially dangerous.

Easy to use and understand, even if you’re not a chemist or compliance expert.
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Effluent de-contamination system is mainly used in bio-pharmaceutical enterprises/laboratories, research institutes and other entities. The bio-active waste water discharged during production often contains some living bacteria and viruses of great hazard. Sterilization is necessary to kill pathogens ...

Our pool of auditors have experience in a wide range of dosage forms and processes, medical devices, API, Excipient, laboratories, storage sites and service providers.  Each auditor is selected according to their expertise and experience and is assessed for suitability before engaging in a client ...

The most modular, flexible and comprehensive solution covering Track & Trace compliance at all levels: enterprise (level 4), production plant, packaging line and warehouse, to ensure traceability compliance for EU-FMD, DSCSA and any other regulatory requirement for pharmaceutical products. A platfo...

Zenovel provides end-to-end GCP services to support sponsors, CROs, and clinical research organizations across the clinical development lifecycle.

Risk-Based Monitoring (RBM) • BA/BE, PK/PD, and Phase I to IV Clinical Studies • Bioanalytical and PK-Stat Monitoring • Medico Monitoring Clinical ...

Biological evaluation plans & reports (BEP & BER) Clinical evaluation plans & reports (CEP & CER) Submission support (US FDA, UK & EU MDR) Toxicological risk analysis Biological gap analysis PSUR (Periodic safety update report) Post market surveillance

QP Release into UK & EU market

https://eramol.com/clinical-services-category/eu-uk-qp-release/