Site Quality Services

PTS can provide pharmaceutical consulting services to assist your company in design and installation of GMP facilities and mock regulatory audits, review of your quality systems including your CAPA plans, or any of the following services.

GLP Audits

GCP Audits

CMC Reviews

GMP Inspections

QA Training

Services

Cellular & Tissue Products Research & Regulatory Assistance

Clinical & Bioequivalence Testing

US agent and Advisory

Drug, Device & Biologics Applications

Drug & Biologics Licensing

Formulation & Product Development

Design, Construction & Qualification of Facilities

Operations Management Services

Pharmaceutical Manufacturing Assistance

Preclinical and Animal Pharmacokinetics

Regulatory Services and Quality Assurance Audits

Site Quality Services

Sourcing Active Pharmaceutical Ingredients and Other Ingredients

Marketing and Sales Related Regulatory Assistance

Pharamacutical Consulting

DEVELOPMENT

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

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APPLICATION

Filing & Managing all of the Processes for FDA Drug Applications

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COMPLIANCE

FDA and Global Regulatory Compliance and Submission

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MANUFACTURING

Complete Facilities Design from inception to full FDA qualification

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