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10 Reasons for ChemCon

Material for

  • Clinical studies
  • Registration
  • Commercial specialty applications
  • Orphan applications

GMP Production

  • Organic small molecules
  • Inorganic chemistry
  • Polymer chemistry
  • Purification and derivatization of natural products
  • Handling of highly potent, cytotoxic, and controlled substances
  • Analytical chemistry
  • Process engineering
  • Design or modification of dedicated equipment

Chemical Expertise

  • APIs
  • Excipients
  • Delivery agents
  • Provocation substances
  • Diagnostics
  • Dietary trace elements for injectable application

GMP Production

  • Technical-grade material
  • Ultrapure fine chemicals
  • cGMP-compliant material
  • Injection, ophthalmic, topic, oral grade
  • Quality control
  • Heavy metal analysis
  • Impurities analysis
  • Method development and validation
  • Release analysis
  • Stability studies
  • Reference standards
  • Chemical characterization
  • Process monitoring

analytical services

  • Detailed, tailor-made offers are flexibly adjusted to your requirements
  • Transparent overview over expected timelines and costs
  • Face-to-face fine-tuning of proposals, for example combined with a visit to our facilities, at your site, or over the phone
  • Chronological development modules can be ordered subsequently
  • Adjustments to the modules are possible at any stage of the process
  • A designated project manager will be your personal contact throughout your project
  • Weekly project reports keep you up-to-date throughout your project and you benefit from a transparent, cost- and time-efficient progress

Synthesis and Process development

  • cGMP compliance from the sourcing of the starting material to the correct regulated shipment
  • regulatory advice regarding the recent increase in regulatory pressure on the supply chain
  • comprehensive cGMP documentation: ASMFs, DMFs, and master documents such as batch records, cleaning records, validation documentation, release protocols, labelling records, certificates of analysis, and certificates of conformity
  • support filing regional dossiers (DMFs, ASMFs) or filing on your behalf

Quality and Regulatory

  • ChemCon meets or exceeds all legislative requirements for health, safety, and waste disposal
  • Track record of handling highly active pharmaceutical ingredients safely
  • ChemCon is privately owned, independent, and not affiliated with any pharmaceutical company
  • Any intellectual property generated during your project will be your intellectual property, unless otherwise agreed.