Services · Document Preparation
Rather than building an additional position or outsourcing your documentation processes to an external provider, we take on your time-consuming documentation processes according to your individual specifications. Professional responsibility remains clearly defined throughout: the tasks are handled by a named, qualified consultant within your organisation. This combines efficient relief with transparency, personal accountability and preservation of your corporate identity.
Non-binding and confidential. Answer in one to two working days.
Every week your quality department spends preparing documents is a week it lacks for what really matters: production and the release of the batches produced.
The question that matters
We do not invent anything. The basis is your existing documentation, your processes and structured technical discussions with the people in your organisation who actually do the work. We then write using your template, in your corporate identity, in a way that fits your existing document control system. You receive it in editable form, so you can maintain it yourselves later without us. Your effort lies in the discussions and the approval, not in the writing.
Preparing and maintaining numerous documents ties up resources and capacity that you need elsewhere. Let us take this work off your hands. Preparation always follows your specifications, so that the corporate identity of your documents is preserved and they integrate seamlessly into your existing document control system.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationWhat already exists, in what form, which template applies. We work with your system, not against it.
One or two meetings with the people who know the process. This is your actual effort.
We write in your corporate identity, consistent with your document control.
You review, we revise, you receive the editable file for your own maintenance.
Typical initial situations
The Site Master File is missing or years out of date, and the authority has announced its visit.
Your people can write, but then other things stall. Writing is the task best suited to being outsourced.
The CMC section of the dossier or the IMPD needs to be finalised, and there is no one in-house able to write it.
The risk assessment is overdue. Where needed, our laboratory can supply the analytical confirmation alongside it.
Responsibility
You will be given the name, role and direct extension of the person who will be dealing with your issue. Before the start of the contract, not afterwards, and not as a team, but as a person. But always with a strong team in the background.
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
Case studies
Anonymised projects from exactly this service, with initial situation, procedure and the final outcome.
We clarify your questions in the initial consultation. Dr. Olaf Mundszinger takes the time for it.
Arrange an initial consultationYour corporate identity is fully preserved. We work in your templates, your layout and according to your specifications. In the end, it is your document in your QM system. We take on the time-consuming drafting, not the identity.
At A&O Pharma, qualified, experienced consultants and Qualified Persons under § 14 AMG work in-house. They know the substantive requirements for documents from their own practice. You receive a named point of contact, backed by a strong team.
Yes. We prepare the nitrosamine impurity risk assessment for medicinal products and active substances based on your product and process data. Where required, we involve our GMP-certified analytical laboratory for data-based assessment.
Fully. We deliver robust drafts. Review and approval take place exclusively with you, in your QM system. The documents remain your documents. We take the drafting work off your hands, not the responsibility and authority.
For a time-limited backlog of documentation, for example ahead of an audit, a marketing authorisation or a new product launch, you avoid building a permanent position and carrying long-term staffing risk. Your internal resources can continue focusing on their core tasks, and you pay only for the additional drafting work actually required.
Among others: Site Master File, SOPs including appendices and forms, Product Quality Review, manufacturing and testing instructions, quality policies, excipient risk assessments, elemental impurities risk assessments, validation and qualification plans and reports across all phases, and CMC sections of marketing authorisation dossiers or the IMPD.
Services that are often used together
Call us or write three lines. You will reach someone directly who can assess your subject professionally.
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.
