New Drug Development

Jeiven Pharmaceutical Consulting, Inc. (JPC) can help bring your drug or device to market. Our experts can assist with:

GLP Toxicology Support

  • Assist in developing a pre-clinical toxicology strategy
  • Review toxicology protocols
  • Identify a capable toxicology laboratory
  • Audit laboratory for GLP compliance and provide report
  • Provide on-site monitoring of studies
  • Audit toxicology reports
  • Review IND summaries prepared by toxicology labs

Pre-Clinical Analytical Support

  • Identify laboratory capable of developing and validating bioanalytical and analytical assays
  • Audit one or more laboratories for GLP/GMP compliance and provide report
  • Provide on-site monitoring of development and validation 
  • Approve method validations/protocols
  • Prepare CMC section in FDA user-friendly format

Formulation Support

  • Identify a laboratory capable of formulation development
  • Lead the formulation development efforts
  • Evaluate early formulations, including preliminary stability data
  • Initiate stability protocols, monitor results, and prepare reports
  • Develop initial specifications as a basis for GLP/GMP manufacturing

GLP/GMP Manufacturing Support

  • Audit facilities for manufacture of drug substance and/or drug product for GLP/GMP compliance and provide report
  • Review batch documentation prior to manufacture
  • Provide on-site monitoring of the manufacture
  • Review batch documentation before and after manufacture 
  • Approve release of drug substance and/or drug product
  • Author stability protocol
  • Identify laboratory to conduct stability studies according to FDA/ICH guidelines
  • Monitor stability results
  • Prepare stability summary report for IND

Clinical Packaging, Labeling, Distribution and Reconciliation Support

  • Identify facility capable of warehousing, packaging, labeling, distribution, and reconciliation of clinical supplies
  • Audit facility for CGMP compliance
  • Author the clinical supplies section of clinical protocol
  • Prepare draft label copy, circulate copy, and ensure that study drug labels comply with approved copy
  • Review packaging and labeling documentation before operation begins
  • Monitor (QC) operation
  • Audit documentation after operation is completed
  • Ensure that return supplies are correctly reconciled

Quality Assurance and Regulatory Support for GLP, GCP and GMP Activities

  • Prepare FDA briefing in preparation for pre-IND meeting
  • Compile necessary documentation for the CMC section of IND
  • Author the required SOPs to support all GLP/GMP activities
  • Provide the required GLP/GMP training
  • Author the CMC section in an FDA user-friendly format (e.g.: eCTD format)
  • Provide selective GCP QA for clinical CRO activities
  • Serve as GLP/GMP consultant at FDA meetings

Address :

6 Jacobs Lane
Scotch Plains, New Jersey 07076