Regulatory Compliance and Consulting
Regulatory Compliance and Consulting Companies (29)
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 (40)
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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 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 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 Auditing, Consultancy & Training
EU GMP / EU GDP Auditing, Consultancy and Training
We support pharmaceutical manufacturers and supply chain partners in achieving and maintaining compliance with EU regulatory requirements. Our services strengthen quality systems, improve inspection readiness and support sustainable GMP / GDP complian...
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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 Quality Compliance Services
Ideolon’s Quality Compliance services are designed to help pharmaceutical companies strengthen their regulatory posture and build a robust quality system. We provide comprehensive support including gap assessments, mock regulatory audits, QMS evaluations, data integrity reviews, and CAPA planning and closu...
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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 Batch release
We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG).
Our services at a glance: • Batch release in accordance with EU GMP Annex 16 by our QPs • Batch certification for human and veterinary...
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Product Pharmacovigilance / Drug Safety
We are an experienced and interdisciplinary team. Based on good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.
Pharmacovigilance services at a glance:
• Adoption of responsibility as EU-QPPV and graduated pla...
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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 DG Assessor
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.
q...
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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 Ultra filter system
Ultra Filter System is applied in downstream purification and separation of biological products, removal of endotoxins in injections, desalination of small nucleic acid products, and solvent removal in the peptide industry, it can provide concentration and liquid exchange functions, as well as clarif...
Upcoming Events
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25 Aug 2026 - 27 Aug 2026





