Regulatory Assistance and Quality Assurance Audits
PTS Consulting Global Services provides national and international regulatory and product development advice on the development and commercial production of therapeutic, biologic and device products. Practical regulatory and operational experience is a vital part of successful licensure and post-market support for therapeutic product development.
PTS Global Services staff consists of experts in regulatory affairs, pharmacology/toxicology, statistics and drug development program management, and will help you with the regulatory planning and implementation of the correct strategy at the earliest stages to allow for smooth product certification to be achieved on time and in budget, as well as to ensure the validity and accuracy of your product development or study data
PTS Consulting Regulatory Assistance and Services Include :
GCP AUDITS :
Electronic trial master files (eTMF)
Phase I facilities and studies
Institutional review boards
Essential documents/trial master files (TMF)
Investigator sites
Data
Listings
Clinical trial reports
GLP AUDITS :
Studies
Formulation analysis and bioanalysis
Pathology evaluations including contracted reading vendors.
BIOANALYTICAL LABORATORY AUDITS (GCP AND GLP) :
Large and small molecules biomarkers
CLINICAL PATHOLOGY LABORATORY AUDITS :
Safety panels
Flow cytometry
Cell-based assays
Specialty diagnostics
SPONSOR, CRO, AND VENDOR AUDITS :
Clinical operations
IVRS/IWRS
Central reading centers
Safety reporting
Data management and biostatistics
Electronic data capture (EDC)/Remote Data Capture (RDC)
Site management organizations
COMPUTERIZED SYSTEM VALIDATION AUDITS :
Data management systems including electronic data capture (EDC)
Safety Databases
IVRS/IWRS electronic patient reported outcomes devices (ePROs)
laboratory information management systems (LIMS)
CGMP AUDITS :
QC laboratories
Investigational product packaging and labeling facilities
Depots/distribution
STANDARD OPERATING PROCEDURES :
Gap analysis
Review and revision
Preparation
TRAINING FOR :
cGMP
ANDA
eCTD
DMF
SOP
QA
CONSULTING :
Audit plans development
Audit follow-up and review of corrective actions
Preparation for FDA inspections and mock FDA inspections
Patient reported outcomes (PRO)
GLOBAL REGULATORY AFFAIRS :
Electronic facility listing
DMF electronic filing
eANDA number requests;
Electronic drug registration and listing
SPL (structured product labeling) creation; electronic labeler code request
ANDA electronic filing (eCTD format)
FILING DRUG APPLICATIONS AND DRUG MASTER FILES :
ANDA research and development
ANDA writing
ANDA audit
DMF writing
DMF audit
ENGINEERING / OPERATIONS :
Engineering and design review
Maintenance review
Validation master planning
Process and cleaning validation
Pharamacutical Consulting
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