serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

More...

Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

More...

Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

More...

Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

More...


Regulatory Assistance & 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.

accurate-regulatory-submissions 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:

  • Investigator sites
  • Phase I facilities and studies
  • Institutional review boards
  • Essential documents/trial master files (TMF)
  • Electronic trial master files (eTMF)
  • 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
  • Data management and biostatistics
  • IVRS/IWRS
  • Central reading centers
  • Electronic data capture (EDC)/Remote Data Capture (RDC)
  • Site management organizations
  • Safety reporting

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 drug registration and listing
  • Electronic facility listing
  • SPL (structured product labeling) creation; electronic labeler code request
  • DMF electronic filing
  • eANDA number requests;
  • 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
Contact PTS Global Services