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NL Netherlands
Stand No: 41N14
Avivia is an independent specialized pharmaceutical development company engaged in drug repositioning, repurposing and reformulation. Our expertise and capabilities are centered around the development of value-added generic drugs, life cycle management of branded drug products, and complex formulation and CMC development of new drug products (NCE). We operate a hybrid business model combining CRO service activities with internal product development programs, whereby in both cases, we approach ‘development' as not just offering a technical solution but always part of a broader product-oriented strategy.
DE Germany
Stand No: 40F40
Dr. R. Pfleger GmbH is a midsized pharmaceutical company in Bamberg, Germany. It was established in 1945 and is owned by the Doktor-Robert-Pfleger-Foundation which supports medical research and charitable and social causes. We provide a full range of services for the development, manufacture, analysis, storage and distribution of pharmaceuticals, dietary supplements and cosmetics. Drawing on our over 70 years of experience, we supply products to more than 40 countries worldwide. Latest news: Our new R&D area is designed like a manufacturing on a small scale. It is compliant with all GMP-requirements and equipped with modern facilities, like the brand-new capsule filler from Harro Höfliger. We cordially invite you to visit us at our stand 40F40.
GB United Kingdom
Stand No: 61D32
EPP is a GLP compliant Contract Research Organisation (CRO) assisting pharmaceutical companies with pre-clinical environmental sciences testing. We ensure the smooth and efficient registration of your products by following OECD guidelines and can provide bespoke testing as required. We specialise in GLP complaint testing in the areas of: · Ecotoxicology; aquatic, marine and terrestrial · Environmental fate · Fish metabolism studies · Controlled substances · Storage stability · Physico-chemical testing · NMR EPP can additionally support your pharmaceutical registration and QC testing processes by providing custom synthesis of rare or unusual (non-commercially available) analytical reference standards of metabolites, impurities or degradants which are comprehensively certified to GLP compliant standards including by the use of GLP compliant NMR (both qualitative and quantitative).
Sub-event: CPHI
ES Spain
Stand No: 41A51
InKemia generates high technological knowledge to give support to the life science industry through its business lines: co-development, contract research, licensing-out, technological services, competitive R&D grant programs, technical and quality consultancy and training. InKemia's core competencies are chemical synthesis, analytical development, impurity studies, biotechnology and bio-catalysis, quality control and EU release.
GB United Kingdom
Stand No: 40F33
Helping our clients achieve Total Quality Assurance through custom, flexible, contract services from a single source, our scientists, auditors and regulatory experts work with you at every stage of development, providing GMP and CMC Laboratory Services, GMP Auditing, GLP/GCP Bioanalysis, Regulatory and Toxicology Consulting and Pharmaceutical Manufacturing Support. Our Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) laboratory network have provided high quality technical services for some of the world's largest and most innovative pharmaceutical companies. GMP and CMC Laboratory Services We provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs seeing you through preformulation, formulation and product release. Our capabilities include centres of excellence for method development and validation, analysis, stability studies, extractables and leachables, solid state characterisation, cGMP quality control testing and cGMP batch release testing. Our teams have specialist expertise for complex medicines and drug delivery systems such as inhalation drug product development for pulmonary...
GB United Kingdom
Stand No: 40D35
LGC is an international life sciences measurement and testing company. Operating from state-of-the-art facilities to GLP, GCP and cGMP standards, LGC has leading capabilities in CMC, with particular specialties in materials science and pharmaceutical analysis. In support of the development and manufacturing of small and large molecule drugs, LGC provides method development, ICH validation and routine testing services. We offer unknown impurity determination, structure elucidation, compatibility studies, stability storage and testing. We are a leading provider of extractables and leachables studies and elemental impurity analysis. Our World-class material characterisation capability supports formulation development and manufacturing. LGC also has a state of the art bioanalytical capability in high-integrity analytical science and expertise spanning small and large molecules, biomarkers, molecular biology and microbiology.
Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Reserach Organisition) established in year 2005. Presently we are US-FDA accredited Facility We are specialized in research via synthesis of complex and difficult to make compounds, innovative organic molecules to support and accelerate the drug discovery research of pharma and biotech companies. We adapt unique synthetic approaches and execute in robust ways for making complex and unknown impurities with their characterization data. Thus we make the drug discovery process more efficient, cost-effective while maintaining the highest standards of quality. With the collective efforts of our team of 130 scientists so, far, we have performed more than 300 method validations & many of these validation reports submitted to EU & US & sought approvals. Work is carried in line with the ICH and the GMP guidance. Our experience, combined with state-of- the-art laboratories and manufacturing facilities lets us become an...
Sub-event: CPHI
IT Italy
Stand No: 40B40
Since 2005 PolyCrystalline provides reliable solutions to optimise and control the crystallisation process of Active Pharmaceutical Ingredients for pharmaceutical companies. Our mission is to support our clients during drug development, helping them to reduce batch failure, avoiding costly crystallisation issues and overall offering greater confidence in drug quality during manufacturing. We can support you from early-phase drug discovery to kilogram supply. We are a high performing cohesive team of trained chemists and analysts, with more than 10 years of experience in the development and optimization of APIs crystallization. We care about results and innovation based on sound science and the use of modern technologies.
BE Belgium
Stand No: 42C23
Quality Assistance SA is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. Quality Assistance assists its clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using state-of-the-art, product-dedicated expertise in analytical sciences. For each customer and each project, Quality Assistance designs customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs. Founded in 1982, the company holds a unique position on the market with 140 highly qualified professionals and all of its laboratories on one site: Bioanalysis (PK/TK/Immuno), bioassays, biochemistry, chromatography, Elemental Impurities, Mass Spectrometry, microbiology, molecular biology, protein characterisation. Quality Assistance is an...
BE Belgium
Stand No: 42C31
Toxikon is a preclinical CRO with ISO, GMP and GLP accreditations in the USA and Europe. Both laboratories are registered with FDA and provide over 30 years of experience in product development services. We support pharma, biotech and medical device industries to deliver exceptional product development services from concept to final product. With our in vivo capabilities ranging from mice to non-human primates, we can provide early proof-of-concept studies and full GLP toxicology studies to support your IND/NDA submission. With analytical services for impurities, bio-analytics up to stability testing and microbiology. At Toxikon, we take time to design your project.