CMC

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...

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...

To achieve your goals in a regulatory authority meeting, the interaction must be carefully planned and flawlessly executed, leaving the regulatory agency with a good impression of your product and company. This requires expert guidance from professionals who have prior regulatory experience and know the ap...

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...

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...

Expert guidance and regulatory submission support throughout the entire development and launch processes. With over 35 years of experience, we will plan and coordinate every detail of a clear and complete US/European submission. We’ll utilize our extensive regulatory and scientific experience engaging with...

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....

We understand that you are constantly faced with complex projects with tight timelines, finding or freeing up resources to meet those deadlines, and are often dealing with trying to balance your daily work with yet another urgent initiative or critical pipeline project.

ProPharma’s Project M...

CMC involves defining manufacturing practices and product specifications that must be followed and met to ensure product purity and consistency between batches. CMC begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development lifecycle...

Quality and compliance solutions delivered by industry-leading specialists

Our experts provide critical GxP-based consulting services throughout the product lifecycle to help our clients successfully bring products to market and maintai...

Services supporting successful outcomes provided end-to-end

We help clients achieve positive regulatory outcomes using a scientific approach as the driver of success.
As the world’s leading provider of regulatory consulting services, we support our ...

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...

Our services for Quality & Compliance:

- CMC Pre and Postapproval
- Quality Systems Consulting and Operational Quality Assurance
- Audits and Inspection Readiness
- Management of Compliance

1.Custom Synthesis 2.R&D of Synthetic Processes and Custom Manufacturing 3.Contract Manufacturing Service 4.CMC Service for New Drugs

Our team of Regulatory affairs experts make our service offerings stronger. 
Following are our Regulatory offerings:

• Regulatory Operations, Affairs

• Regulatory Intelligence, Information Management COTS

• Regulatory Strategy & Business Consulting

• Health Autho...

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filin...

BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development.

Our experts can advise you on pharmaceutical development strategy and provide oversight for the overall product development process to ensure key development milestones are successfully re...