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One-Stop GMP Consulting and Regulatory Compliance Services

 

Benefit from a consultants team supporting you on all GMP and Regulatory Compliance matters – from GMP audits (current state analysis) to overarching advice and inspection preparation.

 

GMP Auditing – Mock Inspections

  • Analysis of the current GMP status of a site
  • Audit report and improvement measures
  • Inspections of suppliers and contract manufacturers
  • Mock inspections and preparation for EU- and FDA inspections


GMP Consultancy

We support you with the following measures:

  • Monitoring your projects
  • Creating documents for you
  • Building up your quality systems
  • Contacting medicines authorities for you
  • Helping you in obtaining a manufacturing authorisation
  • Advising you about applications for marketing authorisations for medicinal products and APIs (CEP/DMF)


NEW – Daily Business Support for GMP Projects

Our staff is on site 40 hours a week, integrated in your teams and completing the work according to your specific directions. This way you benefit from an efficient support in all your GMP matters by professional and qualified personnel for a defined project.

Possible Services:

  • PQR development and preparation
  • Preparation of stability reports
  • Complaint handling
  • Batch Record Review
  • Quality deficiency reports
  • Release preparation
  • SAP change management
  • Change request control
  • Review of marketing authorisation documents
  • Qualification and validation
  • Organisation of documents (signature, filing)
  • Individual support for a QP
  • Further issues in the day-to-day business
     

We offer you consulting services for all relevant departments and fields of Expertise: 

  

Our consultancy is based on the following Standards: 
  • Aseptic / sterile manufacture
  
  • FDA
  • Biotechnological production
  
  • EU/EMA
  • Solids production
  
  • WHO
  • Production of APIs
  
  • PIC/S
  • Production of excipients
  
  • Pharmacopoeias (EP/USP)
  • Quality Assurance
    
  • Quality Control
    
  • IT/EDP
    
  • Engineering (water systems, HVAC Systems)
    
  • Pharmaceutical development
    



NEW – GCP and GLP Audits and Consultancy

Good Clinical Practice (GCP)

  • Audits of clinical operations and systems with the exception of clinical investigators e.g.
  • Process and system audits of CROs, IVRS (Interactive Voice Recognition Systems), Clinical Trial Supplies, Central Clinical Laboratories and Hospital labs, Computerised systems (e.g. Drug Safety, Clinical Trials Management Systems, Electronic Data Capture systems), In House Phase 1 Units, Data Management and Statistics departments through to the preparation of the clinical trial report Clinical Pharmacokinetics (Clinical PK)
  • Process mapping and business process improvement
  • Validation of computerised systems: either as lead or providing quality oversight

Good Laboratory Practice (GLP)

  • Audits of Drug Matabolism and Pharmacokinetics (DMPK) and Non-Clinical / Toxicology laboratories and departments (both in-house and at CROs)
  • Process mapping and business process improvement
  • Validation of DMPK LIMS
  • Validation of LC-MS CDS for bioanalysis
  • Review and critique of bioanalytical method validation reports
  • General consulultancy on pre-clinical development