Regulatory Compliance and Consulting

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...

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...

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 produces GRI-aligned and CSRD-compliant sustainability reports for pharmaceutical companies and their suppliers.


Following the Omnibus I Directive (EU) 2026/470, mandatory ESRS reporting now applies to undertakings with more than 1,000 employees and over EUR 450 million tu...

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 high-pressure homogenizer system forms modular equipment through high-pressure homogenizer devices, process tanks, pipelines, instruments, and control systems, serving the following industries.

Need to know the HS / CN / Tariff code and duty for a chemical

Upload, draw or paste your chemical structure. Let Expedichem do the rest. ExpediChem allows you to simply calculate this for any country in the world. Designed for both chemists and non-chemists. Enter a chemical...

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...

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...

We provide regulatory and PV services, which can be tailored to suit individual client needs.
Our regulatory support includes Marketing Authorisation sourcing, MA transfer, ongoing licencing support, CMC authoring and preparation of type I and type II variations and submission to EMA and national he...

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/

Thépenier Pharma & Cosmetics provides regulatory affairs support to help partners ensure compliance across pharmaceutical and cosmetic markets. From dossier preparation to coordination with authorities, our team helps ensure GMP-aligned and market-appropriate documentation for domestic and interna...