Viewpoints

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.

Pharmaceutical Technology marks 40 years covering the bio/pharma industry.

Pharmaceutical Technology marks 40 years of publishing.

The author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

New reports indicate that drug prices are slowing compared to other healthcare costs.

Biomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.

New study will reveal bio/pharma practices and performance on quality issues.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

Philadelphia plays host to CPhI North America on May 16-18, 2017.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

Reducing regulatory roadblocks requires more than the stroke of a pen.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?

Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

Rookie API developers beat pharma at its own game.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

The editors seek drug development experts to contribute technical articles for 2017.

Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization

Pricing of a lifesaving allergy treatment raises concerns.