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Meanwhile, PDG issues more DSCSA guidance on data interoperability.

HDA Seeks to Limit FDA Enforcement Discretion of DSCSA Come November, Raising the Burden on Some Manufacturers

Citing FDA’s slow guidance, the American Pharmacists Association is requesting delay in November 2023 DSCSA enforcement.



Pharmacists Push for Delaying DSCSA implementation 

How taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information


Benefits of Structured Content in Preparing Data for Regulatory Submissions

While this concern is causing ripples in the global supply chain, technological and regulatory advances can help address the issue

Drug Shortages: A Chronic Problem, but New Opportunities Present Themselves

Wholesalers continue to worry about manufacturer commitment to timely compliance 

HDA Annual DSCSA Readiness Survey Shows Progress but Gaps Remain 

Steve Gens is the Founder of Gens & Associates.

Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape

After a Decade of Regulatory Transformation, What’s Next?

Allows CDMO’s regulatory, consulting services to further expand into the pharma market

Pace Life Sciences Purchases Biopharma Global

Law firm to feature life sciences practice in New Jersey and Philadelphia

Barnes & Thornburg Expands East Coast Presence

Dr. Eduard Cayón is a pharmaceutical industry consultant at bespoke technology and manufacturing supply chain compliance consultancy TDV. He is also the founding partner, VP and a director of pharma auditing organization Asociación Fórum Auditorías (AFA) in Barcelona. The two organizations recently merged with Rephine Ltd, to create the leading global force in GMP audit services. The consolidated organization operates from three primary locations: Stevenage in the UK, Barcelona in Spain, and Shanghai in China.

Dr. Cayón, who holds a PhD in Organic Chemistry, has more than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Innovation in pharma manufacturing as paradigms shift and biotech and personalized therapies move through clinical trials at pace

Achieving Efficient, Optimized, and Compliant Production at Scale

Location expands company’s pharmacovigilance, regulatory affairs services

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