Services · GMP and GxP Consulting & QA Support
A process that has not been validated, equipment that has not been qualified, a quality system with gaps, and no one with the time to deal with them. A&O Pharma provides an experienced consultant who sets up your quality management system, validates processes, qualifies premises and equipment from DQ to PQ and puts quality processes in place in line with GMP, for predictable costs and consistent product quality.
No obligation, in confidence. We reply within one to two working days.
As long as methods and processes are not validated and premises and equipment are not qualified, your plant produces stock rather than released product, and your business stalls.
The question that matters
Only rarely does everything need to be redone. What matters is not the scope but a sound, practical risk-based assessment that safeguards productivity and quality after a change. We assess what has actually changed and what it affects, and from that we determine what needs to be validated, what needs to be requalified and how it must be documented. This usually saves far more effort than the assessment itself costs, and gives you confidence that you can continue to produce reliably.
Validated methods and processes and qualified machinery and equipment are essential for manufacturing your products reliably and without errors. They allow you to assure consistent quality at a predictable cost. Poor product quality, by contrast, leads to high and unpredictable costs. Well-designed validation and qualification therefore pay off, both for patients and for you as the manufacturer.
Roles we take on
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationWhat exists, what your goals are and what is missing. Usually more is in place than expected, it just has not been documented.
Together we decide what needs to be created, validated and qualified, how, and in what order.
Creating or revising the quality system, process and method validation, qualification from DQ to PQ. On request, with analytical testing from our own laboratory.
You receive a quality system and reports that stand up to scrutiny. On request, we are with you during the inspection.
Typical starting points
A new site, a new product or new equipment, and the authority has announced an inspection. You need someone who knows what inspectors will look at.
An audit has revealed gaps, and your response needs to be robust, not just fast. An inadequate response only leads to the next finding.
A process is moving to another line or another plant. Without proper transfer and process validation, batch release is at risk.
You are growing, or you need a system for the first time that is more than a collection of files.
Responsibility
You get the name, statutory role and direct phone number of the person handling your project before the contract starts, not afterwards. A named person, not a team.
Business Development
Key areas
Banking apprenticeship, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Risk Assessment and GMP Documentation
Key areas
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
Analytical Development
Key areas
Doctorate in pharmaceutical chemistry
Quality Management and Sterile Manufacturing
Key areas
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
Qualified Person (QP) under § 14 AMG
Key areas
Licence to practise as a pharmacist, doctorate in pharmaceutical analysis, specialist pharmacist in pharmaceutical analysis
GMP Consulting and Training
Key areas
Licence to practise as a pharmacist
Qualified Person (QP) and Head of Production
Key areas
Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry
Qualified Person (QP) and Head of Quality Control
Key areas
Degree and doctorate in chemistry, postgraduate pharmacy programme to acquire the expert knowledge required under § 15 AMG
Case studies
Anonymised projects from this service: starting point, approach and outcome.
Clinical trial sponsor, small biotech company
A new active substance from a non-EU country was to be used in a phase 1 trial as an investigational medicinal product. We provided GMP oversight, pro...
Read the full case studyInnovative biotech company in cancer therapeutics
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classificati...
Read the full case studyMid-sized pharmaceutical company and marketing authorisation holder
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and busin...
Read the full case studyMid-sized company, marketing authorisation holder
A marketing authorisation holder is planning to change its manufacturer. We reviewed the CMC documentation, made recommendations on selecting a contra...
Read the full case studyMid-sized contract manufacturer of medicinal products
A Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an ongoing...
Read the full case studyClinical trial sponsor, small biotech company
Active substance from a non-EU country, investigational medicinal product for a trial in several European countries: we provided GMP oversight, the IM...
Read the full case studyWe will answer your questions in an initial consultation. Sascha Manthei will take the time to go through them with you.
Book an initial consultationBoth. You can commission a single module, such as an audit, the qualification of premises or new equipment, or support for an upcoming inspection. Or you can book the full range, from setting up the quality system through validation and qualification to the inspection, as one end-to-end package. We start where the pressure on you is greatest today.
Responsibility lies with a named, experienced consultant whom you can contact directly. You do not deal with an anonymous ticketing system but with the person accountable for your project. That is the core of our model: personal advice and continuity instead of changing contacts.
We start with a risk assessment and then take you through all four qualification stages: design qualification (DQ) for specification and selection, installation qualification (IQ) for correct installation, operational qualification (OQ) to demonstrate that the equipment functions as specified, and performance qualification (PQ) to demonstrate reproducible performance in routine operation. Equipment and premises are covered alike, each with traceable documentation for reliable production.
We first get a complete overview of your quality system and close the gaps we find in a structured, risk-based way. During the inspection, we support you on site, and afterwards we help you address the observations and define corrective and preventive actions. How much can be achieved in the time remaining depends on your starting point; we give you an honest assessment in the first, no-obligation conversation.
No. We carry out analytical method validation, from method development through the validation plan and execution to the validation report, in our GMP-compliant, fully digitalised laboratory. This also makes the service suitable for companies without their own analytical laboratory, including virtual pharma companies.
We plan the product transfer in a structured way, carry out the process validation at the receiving site and document the outcome in a GMP process validation report. This demonstrates that the transferred process consistently delivers product of the required quality, which is the basis for routine production and batch release.
Services that are often used together
Call us or write a few lines. You will reach someone who can assess your request with real expertise.
As a member of the Life Science Nord cluster, we benefit from a strong, innovative network and work with other experts in the industry on forward-looking developments.
As a registered supplier on Scientist.com, we can also be reached through this platform: companies registered there can send their project requests directly to us.
