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

• 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 (nitrosamines). Fully digitized processes enable fast and efficient processing of your samples.