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.
