Regulatory Compliance

Pharmaceutical companies operate in one of the most dynamic environments. Changes in regulations by leading bodies such as US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for drug manufacturers.
PPSI can efficiently and proactively help to maneuver the daily changing environment.

Drug Development

Bringing one new drug to the public typically costs a pharmaceutical or biotechnology company on average more than $1 billion and takes an average of 10 to 15 years. Our comprehensive portfolio of services, spanning preclinical through post-approval, features integrated laboratory, Phase I-IV and consulting services to provide end-to-end solutions.

Clinical Supplies Project Management

We build solid programs and solve complex clinical trial problems for pharmaceutical and biotech companies such as resource challenges and complications arising from mid-study changes.
Our project management team understands your needs and wants to help you succeed.

Quality Assurance and Compliance

We provide compliance and quality assurance services that are client tailored and fully aligned with FDA EMEA, state and federal requirements.
Our clients know to expect more than just support, they get a partner. As a client of Pharmaceutical Project Solutions, don't only expect our assistance with compliance and quality assurance, but we provide the strategy and training that will help you improve quality systems and mitigate future risk.

Additional Services

Providing comprehensive services for all levels of domestic and international pharmaceutical controlled substance regulation.
We assist with controlled substance scheduling, abuse liability assessments, registration manufacturing processes and DEA record keeping and reporting.