Regulatory Compliance and Consulting
Regulatory Compliance and Consulting Companies (35)
Regulatory Compliance and Consulting News
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News Navigating Cross-Border Pharmaceutical Logistics: Strategies for a More Resilient Supply Chain
This is a feature article written by Nick Fryer, Vice President of Marketing, Sheer Logistics
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News Closing 2024 with Editors' picks of top articles from the past year
Coming to the end of 2024 and it’s certainly been a busy year, for CPHI and for the rest of the pharmaceutical and healthcare industry. Topics of conversation throughout the last 12 months have been varied, touching on the technical, to the polit... -
News CPHI Milan Speaker Spotlight: Pharma Manufacturing and Localisation in Africa
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences.
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News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden...
Regulatory Compliance and Consulting Products (53)
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Product Regulatory, Quality and Technical Support
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...
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Product ESG Supply Chain Due Diligence and Supplier Assessment
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...
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Product CAS SciFinder Discovery Platform
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...
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Product Compliance Management
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...
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Product Method Development, Validation and Transfer
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...
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Product R&D Laboratory of medical devices | CDMO | Regulatory Affairs
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...
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Product High-Pressure Homogenizer System
The high-pressure homogenizer system forms modular equipment through high-pressure homogenizer devices, process tanks, pipelines, instruments, and control systems, serving the following industries.
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Product Expedichem
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...
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Product Track & Trace Pharma Compliance Solution
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...
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Product Rapid Decon Station by Franz Ziel
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...
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Product Vendor Qualification and Audit
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 ...
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Product Clinical Lifecycle Management
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 ...
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Product Consultancy
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
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Product QP Release
QP Release into UK & EU market
https://eramol.com/clinical-services-category/eu-uk-qp-release/
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Product Regulatory Affairs & Compliance Support
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...
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Product GVP-Audits services
As an interdisciplinary team with many years of experience in drug safety, we advise you on all aspects of pharmacovigilance and support you in conducting GVP audits – fully aligned with current GVP guidelines. This includes, among other things, the planning, conduct, and follow-up of your GVP audits.
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Product Contract Analysis
Contract analyticsDevelopment of analytical methods (chromatography – dissolution – particle analysis – titration – wet chemistry)
Formulation screening and compatibility testing for product development
Biopharmaceutical characterization
Specialized analytical methods – special analyses
GMP or ...
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Product Mesned Pharma Consult Center
Our commitment is to make a meaningful difference to patients’ health, founded on innovative science and making the most of the opportunities of new sciences and technologies to the search for new medicines for the Arab world.
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Product Vicky
Vicky is an AI platform for legislation and compliance. It provides companies with a comprehensive overview of both EU and local legislation in one place, shows which obligations apply specifically to their business and what they entail, converts them into an auditable registry for team management and task...
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Product FFS Combination Cap & Material Compounding Production Lines
Looking to establish your own in-house FFS combination cap production facility? JSD provides turnkey production solutions covering cap manufacturing, material compounding, sealing-disc production, and ongoing technical support. Contact JSD today to discuss your requirements and discover how we can help bri...
Upcoming Events
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CPHI Korea 2026
COEX, Seoul, Korea
25 Aug 2026 - 27 Aug 2026 -
CPHI & PMEC Shenzhen 2026
Shenzhen Convention & Exhibition Center (SZCEC), China
16 Sep 2026 - 18 Sep 2026 -
CPHI Milan 2026
Fiera Milano, Italy
6 Oct 2026 - 8 Oct 2026




