Regulatory Affairs

Excipient testing, composition and variabilityExcipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases the exipients are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.

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Lomapharm GmbH provides wide range of services including analysis service. It involves chemical and physical analysis of raw materials, intermediate and finished products according to national and international specifications as well as customer-specific information (microbiological purity, stability t...

The Magnetic Mixing Bag offers a sterile, single-use mixing container designed to maximise mixing performance while minimising disruptive shear. The 5-bladed impeller is floating freely due to magnetic forces minimising risk of particle generation and ensuring a safe and homogenous mixing of product. A...

Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
Core Capabilities:Sterile-fill finish development and manufacturingO...

Our Analytical Services encompass critical aspects of drug development and manufacturing, beginning with Analytical Testing to ensure product quality, employing advanced instrumentation and experienced teams to facilitate compliance. We excel in Method Development & Validation, utilizing HPLC and UHPLC...

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...

MedPharm has developed proprietary models relevant for major disease areas such as psoriasis, atopic dermatitis, onychomycosis and continue to develop new ones through our dedicated innovation group. These sophisticated ex vivo experiments provide additional confidence to clients and their in...

Alfatestlab is equipped with the latest technology platform to provide rapid, reliable and accurate characterization of EVs following MISEV 2023 guidelines. Based on Nanoparticle Tracking Analysis (NTA - Nanosight) and Single-Vescicle Multiparametric Analysis (Leprechaun), our services for EVs of...

We support our clients from early-stage research and preclinical phase to and beyond market approval by providing comprehensive development services, including 

• Developability assessment • Pre-formulation screening • Formulation development • Lyophilization process development • Forced d...

• 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...

From a drug product’s first raw materials to its release-ready batches, our experts rigorously evaluate and verify a product’s quality at key steps throughout the manufacturing process. Analytical services include material testing to verify product quality from the early stages of development, cGMP-com...

From OTC and Rx to diagnostics and dietary supplements, Avéma manufactures a full range of solid and liquid dose products, all manufactured under strict FDA guidelines and cGMP compliance. With an ever-growing portfolio of innovative formulas and a diverse mix of state-of-the-art equipment, our offerings a...

Download our brochure: https://bit.ly/4dzryoA

Pharmaceutical packaging can release chemicals into the drug product that can not only impair its effectiveness, but also be harmful to the patient. Similarly, medical devices can undergo leaching processes during their use that could negatively affec...

Mass spectrometry is among the most powerful analytical techniques available for protein characterization. KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients. 
Our expert team brings decades of experience in protein and p...

Wasdell’s specialised pharmaceutical manufacturing facilities in the North East and the East Midlands are MHRA approved for the manufacture of non-sterile oral liquids with the capability and capacity to extend its services to other dosage forms. We can support the manufacture and packaging for cl...

A correct formulation means greater stability of the active ingredient and provides protection against the stress suffered during the lyophilization process itself.

The selection of the appropriate excipients is really important in the development of a freeze-dried product.

CARBOGEN AMCIS provides comprehensive Drug Substance services, offering expertise in process development, scale-up, and manufacturing of active pharmaceutical ingredients (APIs). With state-of-the-art facilities, the company specializes in high-potency compounds, including cytotoxics, and delivers solu...

Book a private, one-to-one session with the Certification team to discuss issues such as the CEP procedure, CEP applications or inspections, please complete the online form and the team will be in contact regarding an appointment. 

Please book using this url: 
https://www.edqm...

Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Reserach Organisition) established in year 2001. Presently our group consists of more than 130 Scientists with 3 R&D Centres offering its expertise in Custom Synthesis, Impurity synthesis, Isotoped lebelled compound...

The Gasporox sensor module VialArch offers non-destructive Headspace Gas Analysis to be integrated directly onto the production line or into an inspection machine.

This unique laser-based solution is installed on the production line for 100% quality inspection and container closure ...

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

A team of experts serving the network.
POLEPHARMA stimulates industrial and economic development of actors of the French first pharmaceutical sector with actions that promote competitiveness, innovation and attractiveness to the advantage of the job market.

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.

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.

Our quality control department offers a broad range of services from incoming goods testing, in process controls to release of final product and stability testing. Our workflow ensures that all products are safe for market release and simultaneously functions as a feedback tool to help in the optimizat...

Our R&D Services are categorized into 8 streams: • Material Science Services

• Metal and Organic Scavenging Screening Services

• Organic Synthesis Services

• Catalysis Services

• Process Services

• Chromatography and Purification Services

• Method D...

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...

It is a digestive system medication suitable for the treatment of acute upper gastrointestinal bleeding such as duodenal ulcers, acute gastric mucosal lesions caused by gastric ulcers, and compound gastric ulcers.

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:...

Through Recipharm Analytical Solutions™, we support customers with stand-alone analytical requirements. Our analytical development team has experience from developing hundreds of analytical methods every year, supporting development of formulations ranging from powder in capsules and IV solutions to ER tab...

Contract Research Laboratory. Analytical Services (physicochemical analysis, microbiological analysis and stability studies) and EU Import Lab.

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...

Lifecore’s experts have gained the know-how to build processes around your requirements for smooth scale-up and high-quality manufacturing.

Whether we’re your primary partner or a secondary source for manufacturing, we ensure you're fully satisfied with the final produ...

Relying on an experience gained over more than 50 years, OLON represent one of the most extensive know how of microbial fermentation in Europe. The Group, global leader in biomanufacturing, has two Biotechnology Centres located in Italy and is one of the first companies in Italy producing via microbial ...

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...

SGS’ range of services dedicated to biopharmaceutical product characterization bring the most recent developments in testing technology to companies across the globe. In 2010, SGS acquired the M-Scan Group, the world leaders in the application of advanced mass spectrometry
techniques for protein and c...

SANAL® SQ Sodium Chloride Pharmaceutical Quality is our chemically pure product which is suitable for all pharmaceutical applications. Additionally this product is suitable for laboratory testing and chemical applications in manufacturing procees - This product comply with American Chemical Socie...

We offer the quality standards that we apply to our own environment, machines, solutions and processes as services to our customers as well.

We make continuous investments in our specialist expertise. Quality assurance is the focus of our work. To ensure that we can meet your requirements r...

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...

Discovery - Biology, Lead Optimization, Libraries, Synthetic & Medicinal ChemistryDevelopment - Chemical Process R&D, Fermentation, Formulation Development, High Potency, Kilo Lab & Small Scale Manufacturing, Lipid Nanoparticle, Method Development/Material Science, Rare/Orphan, Separation Scien...

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...

Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes characterization of biologics and biosimilars. It includes range of biologics such as: hormones and toxins, biosimilars (proteins and monoclonal antibodies), inn...

We provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs seeing you through pre-formulation, formulation and product release. Our capabilities include centers of excellence for method development and validation, analysis, stability studies,...

Excerpt from the range of services offered by our analytical department: • physico-chemical testing • chromatography • spectroscopy/spectrometry • determination of TOC/TNb (water analysis/cleaning validation) • particle measurement
• elemental analysis
• dissolution testing
• pho...

We provide Method Development and Method Validation for new analytical methods or Method Transfer for Routine Testing according to existing validated methods for raw materials and final products. QACS is GMP/GLP certified.
• performed with UPL...

Intertek offers quantitative immunoassays such as ligand binding assays for toxicokinetic and pharmacokinetic studies supporting biologic preclinical and clinical development. Our capabilities for quantitative immunoassays include developing methods for biologics and biosimilars, method transfer, opti...

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 ...

Almac has extensive experience in the synthesis and analysis of stable (non radio-active) and 14C isotope labelled compounds – from drug discovery through to launch – we can label any compound at any stage, including small molecules, peptides and larger bio molecules.

Our custom radiolabell...