pharma_photo2Ceutical Laboratories, Inc. provides general consulting services in Quality Assurance, Quality Control and regulatory submissions, with specific auditing and developmental services in the areas of manufacturing and testing, preclinical and clinical research.

Quality Assurance and regulatory submissions
Preclinical Testing
Manufacturing and Testing
Clinical Research/Technical Writing
Validation Activities
SOP Preparation and Quality Modules

We also are able to provide clinical monitoring and project management services.

Quality Assurance and Regulatory Submissions

  • Consultation on domestic and international regulatory strategies for drug products
  • Representation of clients to FDA or other regulatory agencies, including meeting preparation and facilitation
  • Assistance with technical writing and documentation
  • Quality GMP, GLP, ISO and GCP audits
    • Compliance and documentation systems
    • Systems, facilities and process/operations
    • Contractors and suppliers
  • Evaluation/development of training systems and training courses in GMPs, GLPs, ISO, and GCPs
  • Evaluation and development of SOP’s, policies, work instructions, and specifications to meet cGMP requirements, including the latest FDA guidelines.
  • Establishment of Document Control functions within Ceutical Laboratories to save time, space, and money.

Preclinical Testing

  • GLP audits
    • Animal facilities and studies
    • Testing laboratories
  • Preclinical protocol preparation/review
  • Final report preparation/review
  • Preparation of all sections of INDs, NDAs

Analytical testing

  • Structural chemistry
  • Analytical method development/validation
  • Primary standard qualification S

Manufacturing and Testing

  • GMP audits
    • Preparation audits for pre-approval inspections
    • Supplier audits
    • API and Finished Product manufacturing facilities
    • Manufacturing, testing, labeling and packaging operations
    • Holding and distribution facilities
  • Review of batch records, QC testing records, and stability studies.
  • Preparation and review of GMP documentation, including master production records, batch records, testing records, stability protocols and reports, development reports, miscellaneous forms, and SOPs.
  • Analytical testing-Chemistry
  • Microbiology.

Clinical Research/Technical Writing

Ceutical Laboratories, Inc. works with its clients to ensure understanding of objectives and results. All applicable regulatory requirements, including ICH guidelines, are followed when preparing and reviewing clinical documents.

  • GCP audits
    • Contract Research Organizations
    • Clinical studies and sites
    • Clinical study reports and data listings
  • Clinical Trial Monitoring – Phase 1 through 4
  • Development of clinical forms/reporting systems
  • Serious Adverse Event reporting/review
  • Write Investigator Brochures
  • Preparation/review of clinical protocols and study reports
  • Clinical document review
  • Preparation of clinical sections of INDs, NDAs
  • Consultation on clinical supplies and drug shipment issues
  • Literature search and review
  • Manuscript Preparation

Validation Activities

  • Preparation/review of validation protocols and master plans (including equipment, assay, shipping, cleaning, computer, software, and facilities validation)
  • Preparation/review of final reports
  • Review and compliance assessment of validation packages
  • Develop plans to comply with 21 CFR Part 11

SOP Preparation and Quality Modules

  • Your facility to meet current cGMP criteria
  • Ceutical Labs can manage the entire Document Control process