API SUPPORT SERVICES

API Support Services

At any development stage and scale of synthesis CordenPharma’s services for contracted customers include all supporting activities that are required to be adequately cGMP compliant such as:

  • >> Process Validation
  • >> Cleaning Validation
  • >> Batch Release
  • >> Analytical Method Development & Validation
  • >> Characterization of Solid-state Properties, e.g. Particle Size Distribution & Polymorphism
  • >> Execution of ICH Stability Studies
  • >> Proof of API Structure
  • >> Identification of Impurities
  • >> Preparation of Analytical Reference Standards
  • >> Regulatory Filing Support

Our facilities support customers with on-site regulatory affairs personnel for the documentation of CMC development projects in the CTD format for convenient inclusion in IND / IMPD / NDA / MAA filing dossiers.


Support Services for Our Contracted Customers

Successful commercialization of a regulated pharmaceutical product is directly related to full compliance with cGMP rules, requiring a high level of analytical, validation and regulatory support. CordenPharma stands above the competition with trained professionals who adhere to the highest possible regulatory standards at all stages of product development.


Analytical Support

Throughout the whole development and industrial lifecycle of all of our APIs we provide analytical support for contracted customers as required to be cGMP compliant.

All API batches are released by independent Quality Control departments. Analytical methods are developed and validated in accordance with ICH guidelines, not only applying to release test methods, but also to In-Process Controls and test methods used in cleaning validation. Stability studies are conducted, including forced degradation studies as well as investigational and formal ICH stability studies.

For all Active Pharmaceutical Ingredients (APIs) structures are proven through instrumental analyses including NMR, LC-MS, GC-MS and X-ray structural analysis. The respective analytical reference standards are prepared and analytically characterized. As required by ICH guidelines, API impurities like side products or degradants are identified through instrumental analysis and reference samples thereof are synthesized.


Validation Support

At all CordenPharma sites validations of all cGMP relevant systems are conducted as required to be cGMP compliant, from risk analysis and execution right through to evaluation and validation reporting of:

  • >> Manufacturing Processes
  • >> Cleaning
  • >> Analytical Methods
  • >> IT-Systems

All relevant production / analytical equipment is qualified according to cGMP requirements


Regulatory Support

CordenPharma is linking together a legacy of expertise to navigate the complex regulations and registration processes necessary to test new Drug Products and bring them to market. Experienced, on-site Regulatory Affairs teams ensure regulatory compliance by preparing and maintaining regulatory documentation such as:

  • >> Drug Master Files (DMFs in USA, Europe, Japan, Canada, etc)
  • >>CMC Quality Module Documentation in CTD Format Suitable for the Submission of IND, IMPD, NDA, and MAA Dossiers
  • >> EP-Certificates of Suitability (CEP)

As required we support approvals of our contracted customers' NDAs and MAAs during registration as well as post-approvals through response to questions issued by the authorities.

CordenPharma’s ability to develop and manufacture APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services, resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.