Services · GMP Document Preparation
Instead of creating an extra position, you hand your time-consuming documentation work to us, prepared to your own specifications. Responsibility remains clearly defined: the work is done by a named, qualified consultant. You get real relief with transparency and personal accountability, and your documents keep your own format and house style.
No obligation, in confidence. We reply within one to two working days.
Every week your quality department spends writing documents is a week lost for what really matters: production and the release of finished batches.
The question that matters
We do not invent anything. We work from your existing documents, your processes and structured interviews with the people in your company who actually do the work. We then write in your template and house style, so that the document fits into your existing document control system. You receive it in an editable format, so you can maintain it yourselves later. Your input is the interviews and the approval, not the writing.
Preparing and maintaining large numbers of documents ties up resources and capacity that you need elsewhere. Let us take this work off your hands. We always work to your specifications, so your documents keep your own format and house style and fit seamlessly into your existing document control system.
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationWhat already exists, in what form, and which template applies. We work with your system, not against it.
One or two meetings with the people who know the process. That is the only real input we need from you.
We write in your house style, in line with your document control.
You review, we revise, and you receive the editable file to maintain yourselves.
Typical starting points
The Site Master File is missing or years out of date, and the authority has announced an inspection.
Your people can write, but then other work stalls. Writing is the task that is easiest to outsource.
The CMC section of the dossier or IMPD has to be ready, and no one in-house can write it.
The risk assessment is overdue. If needed, our laboratory can provide the analytical confirmation as well.
Responsibility
You get the name, role and direct phone number of the person handling your project before the contract starts, not afterwards. A named person, not a team, but always with a strong team behind them.
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Regulatory Affairs
Key areas
Degree in biology with a focus on molecular biology, plant metabolic physiology and enzyme chemistry, over 20 years of experience
Regulatory Affairs
Key areas
Degree in biology with a doctorate, focus on molecular biology, biochemistry and botany, over 15 years of experience
Risk Assessment and GMP Documentation
Key areas
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
GMP Consulting and Training
Key areas
Licence to practise as a pharmacist
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
Analytical Development
Key areas
Doctorate in pharmaceutical chemistry
Case studies
Anonymised projects from this service: starting point, approach and outcome.
Clinical 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 studyClinical trial sponsor, small innovative biotech company
A multi-stage manufacturing process with many manual steps was to be automated in compliance with GMP. The phase 2a trial went ahead, and production t...
Read the full case studyGMP Document Preparation
Tell us in two lines what you need, or call us directly. You will speak to the experts who will be responsible for your project, not to a ticketing system. We reply within one to two working days.
We will answer your questions in an initial consultation. Dr. Olaf Mundszinger will take the time to go through them with you.
Book an initial consultationYour documents keep your format and house style. We work in your templates and your layout and follow your specifications. In the end, it is your document in your quality system. We take on the time-consuming drafting; the documents remain yours.
A&O Pharma has experienced consultants and Qualified Persons under § 14 AMG in-house. They know what these documents need to contain from their own day-to-day work. You get a named contact, backed by a strong team.
Yes. We prepare nitrosamine impurity risk assessments for medicinal products and active substances based on your product and process data. Where needed, we involve our GMP-certified laboratory to support the assessment with analytical data.
Fully. We deliver robust drafts; review and approval take place only on your side, in your quality system. The documents remain yours. We take the drafting work off your hands, not your responsibility or authority.
For a temporary peak in documentation work, for example ahead of an audit, a marketing authorisation application or a product launch, you avoid creating a permanent position and carrying long-term staffing risk. Your own team can stay focused on its core tasks, and you pay only for the drafting work actually needed.
Among others: Site Master File, SOPs including attachments and forms, Product Quality Reviews, manufacturing and testing instructions, quality policies, excipient risk assessments, elemental impurities risk assessments, validation and qualification plans and reports for all phases, and CMC sections of marketing authorisation dossiers or IMPDs.
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.
