Regulatory Compliance and Consulting
Regulatory Compliance and Consulting Companies (30)
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 (48)
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Product PPWR Readiness Assessment for Pharma Packaging
Regulation (EU) 2025/40 (PPWR) has applied across the EU-27 since 12 August 2026. For pharma the exposure is uneven: primary packaging of medicinal products is exempt from the recyclability and recycled-content targets — but that exemption has to be documented, and secondary, transport and e-commerce packa...
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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 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 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 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 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 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 Controlled Substances Squared
When you have a large chemical collection, identifying which ones are controlled is an important but difficult compliance challenge with many different regulations to consider including narcotics, psychotropics, chemical weapons, ozone depleting, dual use, precursors, export restricted and more.
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Product Purified Water Generator
Features: • PWG can applied in industry of pharmaceutical, food, cosmetics and fine chemicals; • Quality of purified water can meet the requirements of WHO, USP, EP, ChP, JP etc; • Capacity: 250-50000l/h(Larger capacity can be customized.); Quality of purified water is always stable at a low...
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Product MIA Import & QP Certification + Contract QPs/RPs
Our MIA (M20117/00001) is available for Import and QP certification. QPs are also available to be listed on client MIA/MIA-IMPs and carry out batch release according to Directive 2001/83/EC (Human).For GDP and distribution, we provide interim RP/RPi services to the pharmaceutical industry.
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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 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 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 AI Ethics & Security
As AI continues to evolve, making sure it’s used ethically is essential. We focus on AI Ethics and Security, helping businesses put responsible AI systems in place that follow global rules and regulations. Our solutions emphasize transparency, fairness, and security to build trust in AI.
- AI Risk Mitig...
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Product Pharmaceutical Turnkey project Consultants
JD Pharma Consultants Pvt.Ltd. is leading Pharmaceutical Project Consulting company offers services from design upto commissioning of Pharmaceutical project.Our services includes Plant layout design, HVAC, Civil, Electrical, mechenical, Clean room design & installation. We provide end to end solutions to o...
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Product CAS Registry Services
CAS Registry Services helps you obtain CAS Registry Numbers® (CAS RNs®), CA Index Names, and substance information for reports, proprietary files, online searching, and regulatory applications.
Upcoming Events
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CPHI South East Asia 2026
QSNCC, Bangkok, Thailand
08 Jul 2026 - 10 Jul 2026 -
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





