scientific consulting services for the pharmaceutical industry

Pharmaceutical Industry

Vitale Scientific Associates’ support to pharmaceutical industries include sample program design, planning and oversight of sample collection design, and protocols for measurement of microorganisms/pathogens and chemical species in consumer product.  We provide assistance with and/or management of laboratory procurements including drafting and issuing technical specification manuals, design, planning and execution of performance evaluation studies and performing evaluations of laboratory proposals.

In addition to expertise in routine analytical chemistry, physical and toxicity testing, we offer expertise in microbial studies, proteomic and metabolomic mass spectral techniques, and the characterization and toxicity testing of nanomaterials.

We provide systematic on-site laboratory audits within the context of industry standards, including FDA, GLP (US and OECD), ISO 17025, and USP method requirements.  We also provide carefully designed and executed blind performance evaluation studies.

Additional Services

  • Laboratory data review and validation.
  • Verification of proper data management through data audits.
  • Forensic science services to identify and allocate sources of chemical and/or microbial contamination.
  • Preparation for ISO 17025 certification and review of certification status.
  • Periodic, scheduled quality system reviews.
  • Establishment and assessment of laboratory records and documentation system.

Our Experience

Vitale Scientific Associates’ senior project scientists, biologists, analytical chemists and data management professionals have rich experience in  providing successful oversight and management of scientific and technical data collection for risk management, regulatory compliance, and litigation support programs.  We have over 30 senior scientists and professionals spanning these disciplines, along with more than 50 staff scientists and data analysts, all with varying project experience ranging from corporate product recall decision matrices, through assisting in-house and contract laboratories for FDA, GLP, and ISO compliance, to highest profile food and environmental contamination projects.