On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
International and US companies rely on the expertise and professional resources of PDG to provide dependable, accurate, and compliant drug safety programmes, pharmacovigilance services, and ongoing assessments of labelling accuracy and completeness.
An experienced post-marketing safety surveillance team
PDG’s array of epidemiologists, clinicians, statisticians, and regulatory experts deliver evidence-based analysis to address the safety and ongoing benefits / risk assessments of your drug products. The company’s services are predicated upon years of successful industry experience and regulatory interactions relating to both generic and brand name products.
Turnkey solutions for post-marketing surveillance of drugs
PDG provides turnkey solutions that include design and implementation of critical standard operating procedures, validation, training, quality control, and quality assurance. PDG safety surveillance activities may include:
- Individual case reports
- Safety database
- Safety reports
- Literature searches
- Safety signal detection
- Risk management initiatives
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...
Pharmaceutical Development Group has announced it will be attending this year's AAPS Annual Meeting and...