Outsourcing

A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.

Moving global manufacturing operations may be more complicated than it appears.

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.

Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.

The outlook for the CMO and CDMO industry may be affected by ever-changing politics.

Analytical products for improved bio/pharmaceutical development.

Cold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Many pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.

Selecting the best partner contract service and fostering a successful relationship requires detailed research and effective communication.

Currently, pharmaceutical manufacturers are said to waste $25 billion on supply chain inefficiencies. Technology offers a way to achieve transparency and results.

Supply chain risk monitoring is crucial for any company doing business today, and it doesn’t have to be expensive.

More life-sciences companies are starting to manage global suppliers holistically.

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

WuXi AppTech acquired HD Biosciences, a preclinical drug-discovery-focused CRO.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

EAG Laboratories offers dermal absorption studies using OECD methods.

High Street Capital acquired Avomeen, a full-service chemical testing laboratory, in late December 2016