Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

Boston Scientific Cyberattack Hits Orders; Global Operations Disrupted as Recovery Begins

Boston Scientific said a cybersecurity incident detected on August 25 disrupted global operations, including information systems used to process and ship customer orders. The medical-device manufacturer activated incident-response procedures and began working with third-party cybersecurity specialists. Disruptions are expected to
  • News
Boston Scientific Cyberattack Hits Orders; Global Operations Disrupted as Recovery Begins

Pharma Engineering Consultants in 2026: Facility Design, CQV, GMP Utilities, and Project Delivery

Successful pharmaceutical facilities depend on smart design, reliable utilities, qualified equipment, and strong engineering controls. This guide explains how specialist consultants support GMP-ready projects, reduce compliance risks, strengthen CQV activities, and improve facility performance from design through handover.
  • Blog, Validation and Qualification
Engineers reviewing pharmaceutical facility design, process engineering, and clean utilities inside a modern GMP manufacturing facility.

FDA Returns to Cipla Pithampur;7 Observations Renew GMP Remediation Pressure

USFDA issued a Form 483 with seven inspectional observations to Cipla Limited’s Pithampur manufacturing facility in Madhya Pradesh after a follow-up cGMP inspection from August 17 to August 25, 2026. The outcome renews scrutiny of a site that received eight
  • News
FDA Returns to Cipla Pithampur;7 Observations Renew GMP Remediation Pressure

FDA’s PDUFA VIII Moves CMC Earlier; Sponsors Gain Time on Facility Risks

The FDA’s proposed PDUFA VIII framework could move manufacturing readiness discussions much earlier in the drug approval process. The plan introduces new CMC facility interactions before submission, stronger communication during inspections and additional engagement after inspection findings. For pharmaceutical sponsors,
  • News
FDA’s PDUFA VIII Moves CMC Earlier; Sponsors Gain Time on Facility Risks

Pharma Consultant Salary in 2026: Average Pay by Role, Experience, Location, and Specialty

Explore current pharmaceutical consultant salary benchmarks across roles, specialties, locations, and employment models. This guide explains how experience, regulatory expertise, GMP knowledge, and contract structure shape earnings, helping life science professionals compare opportunities and plan their next consulting move.
  • Blog, Computerized System Validation
Professional consultant reviewing life science consultant salary trends across regulated pharmaceutical roles, specialties, and locations.

MHRA Recalls Fingolimod Batch; Shelf-Life Signal Changes Its Quality Status

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted a Class 2 recall of one batch of Fingolimod Zentiva 0.5 mg Capsules after shelf-life testing identified a potential risk of metal-particle contamination. Zentiva UK Pharma Limited is recalling
  • News
MHRA Recalls Fingolimod Batch; Shelf-Life Signal Changes Its Quality Status

Testing Flags Superpotency Risk; Vitruvias Recalls Nationwide Thyroid Tablet Lot

Vitruvias Therapeutics is voluntarily recalling one nationwide lot of Thyroid Tablets, USP 30 mg after testing confirmed potential superpotency. The affected lot 504950 was distributed across the United States between January 31 and September 30, 2025. FDA published the company
  • News
Testing Flags Superpotency Risk; Vitruvias Recalls Nationwide Thyroid Tablet Lot

Supply Chain Management in Pharma in 2026: GMP, Cold Chain, Serialization, Shortages, and Risk Management

Explore how the pharmaceutical supply chain connects GDP controls, cold-chain logistics, serialization, supplier oversight, and shortage prevention. Learn practical strategies to strengthen traceability, reduce distribution risks, and build more resilient, compliant pharmaceutical logistics operations across global networks today.
  • Blog, Quality Management System
Visual of pharmaceutical logistics showing raw materials, manufacturing, warehousing, cold-chain transport, distribution, and patient supply.

FDA Halts RGX-121; 5 MRI Findings Push Regenxbio Resubmission Further Out

The FDA has placed Regenxbio’s experimental Hunter syndrome gene therapy RGX-121 on clinical hold after spinal scans identified abnormalities in five study participants. The patients received the treatment about three to six years ago and remain asymptomatic. However, the regulatory
  • News
FDA Halts RGX-121; 5 MRI Findings Push Regenxbio Resubmission Further Out

Pfizer-Labelled EMBLAVEO Seized; Nonfunctional QR Codes Raise Traceability Questions

Karnataka authorities are investigating an alleged interstate drug network after officials seized medicines, expired stock, counterfeit labels, packaging materials and an injection-filling unit worth about ₹4.91 crore from an unlicensed facility near Bidadi. The recovered stock included products labelled as
  • News
Pfizer-Labelled EMBLAVEO Seized; Nonfunctional QR Codes Raise Traceability Questions