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Pharma Project Consultants in 2026: Pharmaceutical Project Management, Validation, and Technology Transfer

Learn how pharma project consultants support regulated projects through planning, engineering, technology transfer, qualification, validation, and GMP controls. This guide explains where project risks emerge, what strong governance requires, and how companies can achieve compliant project handover.
  • Blog, Validation and Qualification
Pharmaceutical engineering team reviewing project plans, validation activities, and GMP project management requirements in a regulated manufacturing facility.

CDSCO Flags 40 NSQ Batches; Sterility and Dissolution Failures Raise QC Concerns

India’s Central Drugs Standard Control Organisation (CDSCO) has flagged 40 batches of medicines and healthcare products as Not of Standard Quality (NSQ) in its July 2026 surveillance results. The samples failed pharmacopoeial or manufacturer specifications across tests including sterility and
  • News
CDSCO Flags 40 NSQ Batches; Sterility and Dissolution Failures Raise QC Concerns

Apitegromab Met Its Trial Goal; Manufacturing Issues Forced Scholar Rock’s EU Reset

Scholar Rock has withdrawn its European application for apitegromab, its experimental spinal muscular atrophy treatment, and plans to resubmit using a different manufacturing site. The decision follows manufacturing compliance, fill-finish facility, and regulatory path issues at the Bloomington, Indiana site
  • News
Apitegromab Met Its Trial Goal; Manufacturing Issues Forced Scholar Rock’s EU Reset

Quality Management Consulting for Pharma in 2026: QMS, GMP Audits, CAPA, and Compliance Support

Pharmaceutical teams face growing pressure to strengthen quality systems, CAPA, and inspection readiness. This article explains where external expertise adds value, how consultants support remediation, and what evidence regulators expect from a resilient, inspection-ready pharmaceutical quality system.
  • Blog, Quality Management System
Pharmaceutical quality system team reviewing GMP compliance, CAPA management, and FDA inspection readiness.

Caplin Steriles Gets 10 FDA Observations; Its Response Now Takes Center Stage

The U.S. Food and Drug Administration completed an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility in Gummidipoondi, Tamil Nadu, on August 21, 2026. The inspection ended with a Form 483 containing 10 observations. Caplin Point Laboratories said
  • News
Caplin Steriles Gets 10 FDA Observations; Its Response Now Takes Center Stage

NATCO Calls 4 FDA Observations Procedural; Response Quality Now Matters Most

NATCO Pharma’s finished dosage formulations facility in Parawada, Visakhapatnam, received a U.S. FDA Form 483 with four observations after an inspection conducted from August 17 to 21, 2026. NATCO described the observations as procedural and said it expects to address
  • News
NATCO Calls 4 FDA Observations Procedural; Response Quality Now Matters Most

Tyra Nears Phase 2 Readout; Dose Strategy Could Reshape Regulatory Evidence

Tyra Biosciences is approaching a key test of its “dabogratinib 3x3” strategy as the Carlsbad, California biotech prepares to report initial Phase 2 data from SURF302 in September 2026. The company is developing the same oral FGFR3-selective inhibitor across two
  • News
Tyra Nears Phase 2 Readout; Dose Strategy Could Reshape Regulatory Evidence

Rare-Disease Drug Pasatru Wins FDA Approval; Regeneron Moves Beyond 2020 Trial Halt

The U.S. FDA approved Regeneron’s Pasatru (garetosmab) on August 19 for adults with fibrodysplasia ossificans progressiva, marking a striking turn for a program whose mid-stage study was discontinued in 2020 after dosing was paused following five patient deaths. The approval
  • News
Rare-Disease Drug Pasatru Wins FDA Approval; Regeneron Moves Beyond 2020 Trial Halt

Overton Tapped for FDA; Pharma Watches What Changes Next

U.S. President Donald Trump on August 19 named White House policy aide Heidi Overton to lead the Food and Drug Administration (FDA), months after former Commissioner Marty Makary resigned. Overton, a physician and deputy director of the White House Domestic
  • News
Overton Tapped for FDA; Pharma Watches What Changes Next

Pharma Consulting Companies in 2026: Services, Selection Criteria, Costs, and GMP Expertise Compared

Compare pharmaceutical consulting services across GMP expertise, regulatory support, validation, inspection readiness, project evidence, and cost. This guide explains when external support adds value and how to select a consulting partner that fits your compliance risks and business needs.
  • Blog, Validation and Qualification
Pharmaceutical consulting team evaluating GMP consulting services, regulatory expertise, validation support, compliance risks, and inspection readiness.