Batch Releases
A&O Pharma GmbH examines and monitors the GMP-compliant manufacturing of your medicinal products and carries out the QP release 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
Professional Consulting
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:
- 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 Method Validation
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
Company Details
- Employees
- 7
- Founded
- -
- Address
- Am Sattel 17, Efringen-Kirchen,baden-Württemberg 79588,germany
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://aopharma.de/
- HQ
- Efringen-Kirchen, Baden-Württemberg
A&o Pharma Gmbh Questions
A&O Pharma Gmbh's website is https://aopharma.de/
A&O Pharma Gmbh's LinkedIn profile is https://de.linkedin.com/company/a-o-pharma-gmbh
A&O Pharma Gmbh has
7 employees.
View email and phone details for 7
employees at A&O Pharma Gmbh.
A&O Pharma Gmbh's industry is
Pharmaceutical Manufacturing
A&O Pharma Gmbh's top competitors are
Krämer Engineering Solutions Gmbh,
Amiprox Gmbh,
42systems Gmbh & Co. Kg,
Abbott,
Surfactobiotech,
Periotrap Pharmaceuticals Gmbh,
Rades Gmbh,
Vivoryon Therapeutics N.v.,
Medac Group,
Thermosome.
A&O Pharma Gmbh's categories are Pharmaceutical Manufacturing
A&O Pharma Gmbh's founding year is 2019
