Chemistry, Manufacturing and Controls (CMC)

Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....

Our drug product pre-formulation and formulation development services can also includes in vivo PK studies, conducted with multiple animal species and a rapid turnaround time. This additional service further extends our full suite offering to our clients while eliminating the need for additional vendor sou...

Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability s...

Cortellis CMC Intelligence™ product is a comprehensive database of guidelines / granular collection of CMC data requirements for initial registration of small-molecule and biologics drugs around the world that can be used to avoid delays in product approval and successfully bring a drug to the market (laun...

SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...

FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies. Our focus is to combine technical leadership in process d...

Gamma Irradiated, Extra Large Cleanroom Facemask with Tyvek® Side Extensions, Green or Blue, with Double Elastic Headbands and with or without Fog-Prevention Adhesive are made from an inner facing of soft cellulose material, an outer facing of spunbonded polypropylene and a 100% meltblown polypropylene med...

BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq...

Appearance and shape: light yellow crystalline powder 

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...

Xedev can perform the clinical production for your spray-drying project.

WuXI STA's comprehensive drug product development platform for oral dosage forms offers our clients a complete line of solutions from pre-formulation development through to final product manufacture at commercial scale. Our capabilities include; 

• Solid oral tablet/capsule (including liquid...

From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...

From early-stage development through commercial support, our experts provide critical GxP-based consulting services. We partner with clients to successfully execute projects throughout the product lifecycle to maintain quality & compliance with applicable regulations and industry standards. qq...

Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch r...

Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laborato...

Cortellis CMC Intelligence product is a comprehensive database of guidelines / granular collection of CMC data requirements for initial registration of small-molecule and biologics drugs around the world that can be used to avoid delays in product approval and successfully bring a drug to the market (launc...

UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.

BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage form...