Registration Support

Product Description

BioChem GmbH offers a wide range of services which includes registration support. Features: IMPD investigational medicinal product dossier, module 3: Quality, ASMF active substance master file, QOS quality overall summaries, QES quality expert statements, application for modification, extension, responding to deficiency letters.

BioChem GmbH

DE
2015

On CPHI since
2

Certificates
100 - 249

Employees

Company types

Contract Service

Compare Add to favorites Added to favorites

BioChem GmbH

DE
2015

On CPHI since
2

Certificates
100 - 249

Employees

Company types

Contract Service

Compare Add to favorites Added to favorites

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Product Biologic drug substance CDMO services

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
Product Biotherapeutics

To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
Product Analytical Services

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
Product Analytical Services

ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership:...
Product Analytical services

Analytical services

In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

GMP for excipients, risk assessment...
Product QACS Pharmaceutical services

QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...
Product CHEMICAL ANALYSIS DEPARTMENT

Spark-Lab Chemical Analysis Department performs qualitative and quantitative analyses in response to the needs of, above all, the chemical industry and related sectors. Research is carried out with the use of high-end, qualified measurement equipment. Routine analyses carried out in Spark-Lab me...
Product Consulting: Quality Management System

Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
Product Analytical Services

Analytical Services: QC Chem/Microbio, stability, etc.
Product Stability tests according to ICH

Neotron Pharma provides Stability tests according to ICH standards (zones I, II, IV). We can carry out stability studies in their entirety (storage + analysis) or provide only storage service. The conditions we can offer are listed below:

- 40°C ± 2°C , 75% ± 5% U.R.
- 30°C ± 2°C&n...
Product Analytical Services - Inhaled Products

With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterise inhaled delivery platforms, especially DPI, pMDI and nebulised products.

To ensure seamless support for your development...
Product Pharmaceutical powder and particle morphology

Intertek offers wide range of pharmaceutical services which includes pharmaceutical powder and particle morphology. It belongs to pharmaceutical analysis services category. It includes dry powder analysis: physical characterisation, particle morphology using malvern morphologi g3, particle size analysis – ...
Product Complex drug formulation

We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...
Product Analytical Testing and Formulation Development

Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer com...
Product Laboratory Services

Laboratory Services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-...
Product Foreign Particles

Merieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentation combined with a pool of experts in different fields.Download our brochure: https://bit.ly/48HKnVs
Product Method Development, Optimization, and Validation Services

At Integrated Analytical Laboratories (IAL), our approach to method development helps reduce bottlenecks and reduces errors. We understand time is of the essence, so IAL provides a consultative approach with our partners to ensure that your new drug product will meet the goals and objectives you a...
Product GC 456 System

SCION 456 GC Gas Chromatograph When your requirements demand more functionality or you want room to upgrade, the SCION 456 easily meets your need. Supporting three injector and four detector positions (including the mass spectrometer) with full independent access, no other gas chromatograph system pr...
Product Hexane(HPLC grade)

Package size including 1L/bottle,2.5L/bottle,4L/bottle.Always keep 1000bottles in stock.
Product GALENIC DEVELOPMENT

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...
Product Analytical Services

Actylis performs routine and non-routine analytical testing for various industries, in support of manufacturing processes, QA/QC functions, R&D projects, and environmental applications. Leveraging state-of-the-art instrumentation, extensive knowledge base, as well as internal, cross-functional competen...
Product Trace Metals Testing and Elemental Analysis

Our experienced analysts apply a strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs, including inductively coupled plasma – mass spectrometry (ICP-MS) or inductively coupled plasma – optical emission spectroscopy (ICP-OES) or ion chro...
Product Analytical Services

With a team of experienced scientists and a robust toolbox of analytical techniques and equipment, Experic can support the life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the formulation, development, ...
Product Wasdell Laboratory Services

By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...
Product Analytical Development and expertise

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...
Product Development

Synerlab provides wide range of services which includes development. Contact us for more information.
Product Innovation & Formulation

Innovation & Formulation: We offer pharmaceutical R&D, feasibility studies, proof-of-concept, formulation development and analytical method development for multiple dosage forms such as solids, semi-solids, liquids, oral films, and transdermal patches. We can work with over 30 pharma technologies f...
Product Analytical Techniques

Comprehensive analysis during formulation development and GMP manufacture is vital to ensure that your drug has optimal delivery properties and stability profile as well as supporting your regulatory submissions.
Product Development Service

Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...
Product Analytical Services for Particle Size Distribution

We offer our lab services for PSD (particle size distribution) measurements, PSD method development and validation. PSD analysis is done by user laser diffraction systems, microscopic imaging and sieve analysis.
Product Analytical Services & EU Batch Certification

Method Development and validation
Stability Studies
European testing & batch certification
Product Ghost-Buster

Welch Ghost-Buster column can efficiently adsorb and remove the impurities from the mobile phase to eliminate their interference to the target peaks.
Product Research & Development Capabilities

PHT International Inc. offers a wide range of services which includes research & development capabilities. Features: it includes process development, process improvement, sample repackaging, sample production, sample analysis. Contact us for more information.
Product Highly Potent Pharmaceutical Principles

Olon relies on one of the most extensive expertise in handling highly potent pharmaceutical principles at global level, has raised the level of containment up to the actual standards and very large scale putting in place a set of primary and secondary containment designed to avoid the active substances...
Product Core Technologies and Services

• API / GMP Manufacturing • Rapid Process Development, Flawless Upscaling, and Economy of Scale-Production • Simulated-Moving Bed (SMB) Chromatography • Heterocyclic, Hazardous and Malodorous Chemistries • Organometallic and Cryogenic Chemistry • Transition-Metal Catalysis • High-Pressur...
Product Sterility Assurance Testing

Nelson Labs is a leading provider of sterility assurance test services for medical device, pharmaceutical and tissue manufacturers for both sterile and nonsterile products. Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. Medical device standards are...
Product Physical Sciences - Preformulation & Solid State Services

Almac's Physical Sciences groups' comprehensive range of services and expertise will help strengthen the success of your product. Identifying and consistently producing a drug in its optimal physical form is vital to any successful drug development programme. It also avoids the need for bridging toxicologi...
Product Formulation Development

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
Product Stability Testing

From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...
Product Development of Formulation

Formulation Development- Cosmetic products
- Medical devices (skin and mucous membranes)
- Oral supplements
- Veterinary products
- Biocidal products
- Topical medicines

Stability tests - evaluation of the stability of cosmetic products, medical devices, food supplements and bioci...
Product Laser Micromachining Services & Systems

From pinholes in stainless steel discs to complex arrays in semiconductor guide plates, we provide a wide range of ultra-high precision laser drilling, cutting, milling, scribing and ablation contract services (and systems) for numerous applications in industry & academia. With over 45 years of experie...
Product cGMP Manufacturing

1. Manufacturing facilities ensure: 1) Production flexibility at various scale 2) Total Production Capacity: 726 m3 including pilot production 3) Potent compound manufacturing (OEL Category 3A, CPT 1 Mug/m3) 2. Various Analytical Capabilities: 1) cGMP QC lab with HPLC, UPLC, GC, LC-MS, GC-MS, NMR, X...
Product FPFs

• Genexol®PM Inj.(Paclitaxel) • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
Product Batch Testing & EU Batch Release / Certification

QP Declaration
QPLab will evaluate the information regarding active substances manufacturing sites of the product, to assess the EU GMP compliance and issuing the QP Declaration.

QP Batch Certification SetupIn this step QPLab will have a complete oversight ...
Product Chirality Measurement Service

- Absolute configuration determination of chiral molecules. - No purification or crystallization required.
-
Product SOFTGELS

At Softigel, we offer much more than traditional softgels, including everything from a single unit dosage form, to multiple delivery systems in a single dose. Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS Classes II, III and...
Product Stability

Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
-Formulation development studies including stress studies
-Photostability (Options I and II)
-Comparator studies
-Thermal cycling/freeze thaw
-Shipping excursion studies
-Long-term stabi...
Product Analytical package

XEDEV provides a broad range of analytical tools including : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : friability, disintegration, hardness, dissolution • Residual solvent determination :...
Product Analytical Development

Idifarma’s analytical development services include the following activities:
- Solubility studies in different media (organic, aqueous and different PH levels).
- Characterization of the thermal profile and identification of polymorphic forms by DSC.
- Impurities profile characterization. q...