Services · Regulatory Affairs
Without a marketing authorisation holder in the EU, even the best product is denied market access. A&O Pharma applies for the marketing authorisation on your behalf and acts as marketing authorisation holder on an interim basis, until it can be transferred to your commercial partner.
Non-binding and confidential. Answer in one to two working days.
A medicinal product ready for authorisation but without an EU marketing authorisation is capital tied up, incurring costs every day without generating any return.
The question that matters
Yes. A&O Pharma meets all the statutory requirements a marketing authorisation holder in the EU must fulfil. We apply for the marketing authorisation under our name on your behalf and hold it on an interim basis. The subsequent transfer to a pharmaceutical entrepreneur in the EU is not a special case but a standard procedure: the transfer to your commercial partner is planned from the outset and set out contractually, so you are never dependent on us.
Two things are essential for the successful marketing of a finished medicinal product: the authorisation granted by the competent authority, also known as marketing authorisation, and its continual updating and maintenance thereafter. Regulatory Affairs covers all matters relevant to obtaining and maintaining the marketing authorisation (or registration) over the long term.
An essential prerequisite for marketing a finished medicinal product is the authorisation granted by the competent authority, the marketing authorisation, along with its continual maintenance. Regulatory Affairs covers all matters required to obtain and maintain the marketing authorisation over the long term. We take on these tasks for you, with named individuals responsible rather than changing points of contact.
You intend to bring your pharmaceutical products to market in the EU, but do not operate there as a pharmaceutical company.
Can you become marketing authorisation holder for our product?
Yes. We meet all the requirements a marketing authorisation holder in the EU must fulfil. We apply for the marketing authorisation on your behalf and hold it on an interim basis. The exit is not a special case but a standard procedure: A&O does not act as the party placing the product on the market or as a distribution organisation, the transfer of the marketing authorisation to your commercial partner or your own distribution affiliate is planned from the outset and set out contractually.
The approach has two stages:
Statutory functions: During the procedure and beyond, we provide the Graduated Plan Officer (Stufenplanbeauftragte) or QPPV under § 63a AMG, the Qualified Person (QP) under § 14 AMG, and the Information Officer under § 74a AMG.
After the marketing authorisation is transferred to your commercial partner or distribution affiliate, we continue to manage Life Cycle Management and pharmacovigilance obligations under § 62 et seq. AMG. We also carry out the mandatory EU batch releases and EU retesting. You decide the scope of our activities.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationTarget markets, procedure and timeframe. We tell you which route is fastest and what it costs.
We review what is available and openly identify what is missing or should be clarified with the authority beforehand.
We compile and submit, respond to deficiency letters and manage the procedure.
We hold and maintain the marketing authorisation until it can be transferred to your commercial partner.
Typical initial situations
You have no legal entity in the EEA and therefore no one who could hold the marketing authorisation. Without this step, the product never reaches the market at all.
It is your first dossier and you have no regulatory department. You need someone who knows the way, rather than learning it in a time-consuming and costly manner alongside development.
Variations, renewals and life-cycle maintenance are piling up while your own specialists work on new products. Maintenance is mandatory, but it ties up the same resources.
You need the application under Regulation (EU) 536/2014 including the IMPD, and the trial start date is already in the calendar.
Responsibility
You get the name, the legal role and the extension of the person who takes over your topic. Before the start of the contract, not afterwards, and not as a team, but as a person.
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
Investigational Medicinal Products and GCP
Key areas
Doctorate in clinical analytics, specialist pharmacist for clinical pharmacy
Quality Management and Sterile Manufacturing
Key areas
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
Development Analytics
Key areas
Doctorate in pharmaceutical chemistry
Qualified Person (QP) under § 14 AMG
Key areas
Licence to practise as a pharmacist, doctorate in pharmaceutical analytics, specialist pharmacist for pharmaceutical analytics
Case studies
Anonymised projects from exactly this service, with initial situation, procedure and the final outcome.
Sponsor of clinical trials, small biotech company
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyInnovative biotech company in the field of cancer therapeutics
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs thro...
Read the full case studyMid-sized company, marketing authorisation holder
Review of the marketing authorisation chapters and quality documents, risk assessments and a robust transfer plan for the planned change of manufactur...
Read the full case studyMedium-sized company. Contract manufacturer of medicinal products
Continuous release of commercial medicinal products following import into the EU, plus advice on changes and operational QM support.
Read the full case studySponsor of clinical trials, small biotech company
A sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal product,...
Read the full case studyWe clarify your questions in the initial consultation. Ute Hegener takes the time for it.
Arrange an initial consultationiMAH stands for Interim Marketing Authorisation Holder. A&O Pharma applies for your marketing authorisations and acts as marketing authorisation holder in the EU on an interim basis. This is relevant if you do not yet have your own marketing authorisation holder in the EU: your product can be authorised without you first having to set up your own EU entity with all the associated regulatory obligations. Once you are ready, the marketing authorisations are transferred in an orderly manner to your chosen commercial partner. Both processes can run in parallel, saving you significant time before your product launch.
On an interim basis. The iMAH role is designed as a bridge: A&O holds the marketing authorisation until it is transferred to a commercial partner of your choosing. You retain control over the product and decide to whom and when it is transferred.
Yes. With us, it is not an anonymous ticket number but a named individual who is available for your project. You know exactly who you are speaking to and can reach that person directly, including by phone.
Both. You can commission individual services such as strategic consulting, a submission, or Life Cycle Management on their own. Equally, you can combine Regulatory Affairs with manufacturing (§ 13 AMG) and analytics under one roof, if you prefer to have everything from a single source.
We prepare and submit marketing authorisation applications and clinical trial applications on your behalf, support Scientific Advice procedures with the authorities, and handle variations and the ongoing maintenance of existing marketing authorisations throughout the product life cycle.
Following a confidential initial consultation, we agree the strategy and procedure together and can move quickly into preparation. The exact timeframe depends on the product, the target market and the chosen authorisation procedure, we clarify this transparently before you commit to anything. You will generally receive a response to your enquiry within one to two working days, without obligation and in confidence.
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.
