The world’s leading biopharma and life sciences companies trust AES to deliver their most critical cleanroom projects. With 40 years and 15+ ISPE Facility of the Year Awards, no cleanroom partner has a stronger track record. We integrate sustainable design, manufacturing, installation, and service under one roof—eliminating supply chain risk, compressing timelines, and serving as your single-source lifecycle partner from concept through ongoing maintenance.
Adlib Software
Adlib is the accuracy authority in AI-driven document automation for high-stakes, regulated industries. As the critical layer in front of IDP systems, LLMs, and RAG pipelines, Adlib ingests messy, multi-format content and transforms it into AI-ready, machine-navigable pipelines. The platform normalizes file types, applies fidelity-preserving rendering and advanced OCR, classifies and chunks content with citation anchors, enriches it with metadata, extracts information into structured data contracts, and validates outputs against each organization’s business and compliance rules. This results in compliant, searchable outputs and high-quality structured data that downstream systems can trust. Across Life Sciences, Energy, Insurance, Financial Services, and other regulated sectors, enterprises rely on Adlib to reduce human-in-the-loop reviews, increase retrieval precision and model accuracy, accelerate decision-making, and lower processing costs. For more than two decades, organizations such as Pfizer, Swiss Re, IAG, and JP Morgan have trusted Adlib to turn unstructured content into reliable, audit-ready data that safeguards compliance, drives performance, and ensures every decision is precise and AI-ready.
Accelsiors Gmbh
Accelsiors is a global, full-service CRO accelerating clinical development with AI-driven insights, Quality by Design (QbD), and patient-centric solutions. From Phase I to regulatory approvals, we optimize trial execution, ensuring speed, compliance, and success. Visit us at BIO 2025 in the German Pavilion to explore how we can advance your next clinical breakthrough. At Accelsiors CRO, we accelerate biopharmaceutical innovation through a science-driven, patient-centric approach. As a global, full-service CRO, we provide tailored clinical trial solutions designed to de-risk development, optimize timelines, and bring transformative therapies to market faster. With a proven track record in global clinical development, we navigate the complexities of modern drug research—from early-stage clinical development to regulatory approvals and patient-centric trials. Our strategic approach, cutting-edge AI analytics, and deep therapeutic expertise ensure seamless execution and measurable outcomes. | Accelsiors CRO – Science-Driven Clinical Excellence Accelsiors is a global, full-service CRO accelerating clinical development with AI-driven insights, Quality by Design (QbD), and patient-centric solutions. From Phase I to regulatory approvals, we optimize trial execution, ensuring speed, compliance, and success. Visit us at BIO 2026 in the German Pavilion to explore how we can advance your next clinical breakthrough. Let’s discuss how we can accelerate your next clinical breakthrough with Accelerant™, our proprietary Penta-Helix approach—a unique integration of science, patient-centricity, Quality by Design, AI-driven state-of-the-art technologies, and speed with cost-effectiveness at every stage of clinical development.
A&O Pharma GmbH
Are you looking for a smart and cost saving solution for the import of your products into the EEA, the EU re-analysis and batch release? If your answer to one or more of the questions is “yes”, then A&O Pharma GmbH is your partner of choice. We provide Quality and Compliance, Regulatory Affairs and Analytical Services fast and efficient. Our Quality and Compliance Services: – QP services incl. takeover of QP function, batch release FDF/IMP – Product import FDF/IMP – GxP issue solving incl. Qualification and Validation, Tech Transfer, and comprehensive risk assessments (incl. Elemental Impurities & Nitrosamines) – GxP Quality System and license applications – Inspection Readiness (EU/FDA) – Vendor Management incl. risk based qualification and audits – QA services: management of CAPA, change control, deviations, complaints, self-inspection, preparation of PQR – Interim Management, staff augmentation – Education and Training Our Regulatory Affairs Services: – Submission of MAA and CTA – Scientific Advise Procedures, communication with Health Authorities – Lifecycle maintenance incl. variations and renewals, product information and labelling texts – Information Officer in accordance with §74a AMG – Support for product launches and Merger & Acquisition projects – Preparation of IMPDs, MAA Dossiers Our Analytical Services: – A state of the art, fully digitalised analytical laboratory – Release-testing / EU-Retest of Finished Dosage Forms (FDF) – Analytical method transfer and validation – Trace analysis by LC-MS/MS (e.g. Nitrosamines in APIs and FDF) – Fast, efficient order processing | QP Services and Batch Release A&O Pharma GmbH examines and monitors the GMP-compliant manufacturing of your medicinal products and carries out the QP release in the EU region according to §16 AMWHV by our Qualified Person according to § 14 AMG through: – Monitoring of GMP-compliant manufacturing and testing throughout the entire manufacturing process – QP release of clinical investigational and comparator products for use in clinical studies of phases 1 – 3 (Annex 13 EU GMP guideline). – EU batch releases of registered medicinal products (Annex 16 EU GMP guideline) – Qualification of your suppliers and manufacturers Regulatory Affairs One of our specialties is supporting your drug approval processes and clinical trial applications as well as the subsequent life cycle management. We provide you with advice and support right from the start and reliably guide you through the complex landscape of regulatory requirements. – Advice on regulatory strategy – Interim Marketing Authorisation Holder (iMAH): Application for marketing authorisations and acting as interim marketing authorisation holder after marketing authorisations have been granted in the EU until the authorisations are transferred to a commercial partner of your choice. – Support with scientific advice processes – Submission of marketing authorization applications and clinical trial applications, communication with authorities, compilation of IMPDs and MAA dossiers – Life cycle management incl. submission of variations and extensions – Information officer according to § 74a AMG, preparation and review of product information texts and labelling – Support for product launches and merger & acquisition activities Strategic GxP consulting and operational QA support Position your company and your product on a high quality level and offer patient safety through the advice and support of A&O Pharma GmbH. In doing so, we are at your side with the following services: – Analytical Method Validation – Establishment and optimization of a QM system – Education and Training – Support for inspection by authorities – Conducting audits – Facillity and equipment qualification – Transfer and validation of processes Analytical services Use our chemical/pharmaceutical analytical laboratory at the Itzehoe site as your contract laboratory for GMP-compliant analysis of your finished goods and raw materials. We develop and validate your analytical methods and carry out special tests, such as trace analysis (e.g. nitrosamines in active ingredients and medicinal products, aflatoxins in plant products). Fully digitized processes enable fast and efficient processing of your samples.