Consulting services encompass a variety of areas

GMP Inspections & Remediation

We offer comprehensive support for inspection readiness, assist with audit responses to National Authorities, and can coordinate the remedial measures necessary to fulfill commitments to both the FDA and EMA. Our services also encompass conducting third-party facility assessments, covering aspects including data integrity and alignment with current regulatory standards, including Eudralex Annex 1.

GMP Audit Services

Our expertise includes performing mock audits and GMP assessments in compliance with US CFR 21, Parts 210 and 211, and EU Eudralex Vol 4. Our comprehensive audits can cover documentation, facilities and equipment, personnel and training, material management, manufacturing, quality control, supplier management, regulatory compliance, data integrity, and validation enabling us to identify any non-compliance issues and deliver actionable recommendations for corrective actions.

Quality Assurance (QA)

Quality Assurance (QA) services encompass deviation review and management, CAPAs, change management, and all phases of process development and manufacturing, from process design to commercial GMP production. We specialize in assisting clients in establishing and maintaining quality systems that fully comply with rigorous regulatory requirements and industry standards.

Process development

Process development encompasses assistance with upstream and downstream Quality by Design (QbD), process characterization, scale-up, and technology transfer, all aimed at enhancing efficiency, cost reduction, and ensuring product quality. We collaborate closely to develop and optimize processes that are robust, scalable, and compliant with regulatory standards.

Manufacturing services

Manufacturing services encompass the full spectrum of drug substance (DS) and drug product (DP) production, spanning from initial development stages to commercial manufacturing. We provide guidance on facility design, equipment selection, process validation and other critical factors to ensure successful production. Our technology transfer services help clients transfer processes and manufacturing operations to new facilities or external partners and Contract Manufacturing Organisations (CMOs).

Regulatory CMC

Regulatory CMC services provide expert guidance in drug development, covering key milestones including IND, NDA, BLA, and MAA submissions. Our support extends to managing post-approval changes, ensuring a smooth regulatory process while maintaining compliance. With a comprehensive approach, we empower businesses to navigate the dynamic regulatory landscape and optimize product lifecycle management strategies.

Get in touch

We look forward to the opportunity to work with you remotely or on-site to support your biopharmaceutical development and manufacturing needs. To contact us, please email contact@appliedbiopharm.com with your information and a brief description of your enquiry and we will respond as soon as possible. If you prefer to speak with someone directly, please feel free to call on

+353 (0)873634486

(UK/GMT)