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Drug Master File Document Production Services In Europe
41 services found
by:Alfred E. Tiefenbacher (GmbH & Co. KG) based inHamburg, GERMANY
In addition to offering an extensive portfolio of in-house developed generic drug products across indications, AET has started the development of biosimilars and innovative product designs. AET provides a comprehensive service from project concept (including global portfolio and IP strategy and competitive product design) via product development and registration through to production, timely ...
by:Nanolytics GmbH based inPotsdam, GERMANY
In addition to self-association behavior (e.g. desired oligomerization), the conformational status of proteins and other biomolecules (e.g. denaturation, misfolded conformers) is crucial for understanding molecular functions and evaluate stability/safety/efficacy issues of drug products. Therefore, discriminating between size and conformation variants is an ubiquitous task in characterizing the ...
Manufactured by:Perrery Farmaceutici S.r.l. based inPescantina (VR), ITALY
Pharmaceutical innovation is a complex creative process, which involves much more than, in fact, research. An important task of the system of creation and introduction of new drugs into production is to ensure interrelation with other enterprise processes related to the drug life-cycle. This approach makes it possible to ensure the quality of the product along the whole technological chain, that ...
by:IUCT based inMollet del Vallès, SPAIN
IUCT is authorized by the General Inspection and Control of Medicines of the Spanish Drug and Health Products Agency as pharmaceutical drug manufacturer (4155-E). For this has a manufacturing plant of approximately 200 m2 and laboratories for the analitycal ...
by:BioConnection based inOss, NETHERLANDS
When your product leaves our facility, it needs a few additional steps in order to be ready for the clinic. These steps can also be provided by BioConnection. Depending on your needs and requirements, we can setup the further chain into the clinic. It’s a total package! ...
Manufactured by:ApiJect Systems, Corp. based inStamford, CONNECTICUT (USA)
Offering Design, Engineering and Testing of ApiJect’s High Volume Process for Manufacturing Single-Dose, Prefilled ...
by:Ardena Holding NV based inMariakerke, BELGIUM
Our services include: Primary packaging of in-house or externally produced drug product (capsules, tablets, …) in different types of containers (bottles, tubes, sachets, …). Secondary packaging including patient kit assembly and labelling ready for use in the clinic. Use of tamperproof primary and secondary packaging materials. Preparation and translation of multi-language label ...
Manufactured by:Rentschler Biopharma SE based inLaupheim, GERMANY
Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process. ...
by:Ardena Holding NV based inMariakerke, BELGIUM
At Ardena, we are experts in writing scientific and technical reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout to ensure consistency, completeness and ...
by:Vetter based inRavensburg, GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
Manufactured by:CELONIC Group based inBasel, SWITZERLAND
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling batches, our scientists are highly experienced in keeping ...
Manufactured by:RheaVita based inGent, BELGIUM
During freeze-drying, biopharmaceutical and other products require protection against dehydration stress during freeze-concentration and drying. Therefore, a suitable formulation strategy is essential to guarantee the long-term stability of drug products. This strategy could include adding protectants to withstand the dehydration stress, selecting a suitable buffer to maintain a constant pH ...
Manufactured by:CELONIC Group based inBasel, SWITZERLAND
ProJect Pharmaceutics* builds quality into formulation and processes and applies high-throughput predictive stability technologies (Predictive Formulation Analytics, PFA) to ensure manufacturing consistency. Using such a regulatory-compliant Quality by Design (QbD) step at an early stage will result in an accelerated and risk-mediated downstream process (DSP) development. It will also generate a ...
Manufactured by:ApiJect Systems, Corp. based inStamford, CONNECTICUT (USA)
Our device and BFS manufacturing experts will work with your team to fill-finish your drug product in one of our customized prefilled drug delivery systems at scale. ...
by:Neunco Pharmaceutical based inBoxmeer, NETHERLANDS
It is an internal company document used in the purchasing process to authorise the requisition of materials (here drugs) before initiating a purchase order. An indent is an official order or requisition for medicine and supplies from the medical ...
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Biological drugs are pharmaceutical drug product manufactured in, extracted from or semi synthesized from a living organism or from biological sources. Our professional scientists have rich experience in biological and pharmacological research of multiple biological drugs including peptide drugs, protein drugs, antibody drugs, antimicrobial drugs, vaccines as well as drugs involved in different ...
by:Revvity Gene Delivery (formerly SIRION Biotech) based inHamburg, GERMANY
At Revvity, we work with you to expedite the development of gene therapy vectors. ...
by:Biovian Oy based inTurku, FINLAND
Biovian is a One-Stop-Shop CDMO for bacterial and yeast-based production of Drug Substances and Drug Products. Our microbial production services include GMP production of recombinant proteins and plasmid DNA for vaccines. The microbial GMP-manufacturing unit of Biovian is equipped with state-of-the-art fermenters, harvesting equipment, and a choice of downstream purification capabilities. ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced degradation studies according to ICH guidelines Q5C and Q1B. ...
Manufactured by:Creative Bioarray based inShirley, NEW YORK (USA)
Advances had been made towards the use of in vitro human skin equivalents/models for dermal drug and cosmetic product testing. In vitro Skin Models (Human Skin Equivalent, FTSK, HSE) used under defined test conditions offer several advantages: i) since most models are composed of primary human cells, inter-species extrapolation is avoided; ii) in contrast to human skin specimens, repeated ...