Services · Regulatory Affairs
Without a marketing authorisation holder in the EU, even the best product cannot reach the market. A&O Pharma applies for the marketing authorisation on your behalf and acts as interim marketing authorisation holder until the authorisation can be transferred to your commercial partner.
No obligation, in confidence. We reply within one to two working days.
A product that is ready for authorisation but has no EU marketing authorisation is tied-up capital: it costs money every day and earns nothing.
The question that matters
Yes. A&O Pharma meets all the legal requirements for a marketing authorisation holder in the EU. We apply for the marketing authorisation in our name on your behalf and hold it on an interim basis. The later marketing authorisation transfer to a company in the EU is a standard procedure, not an exception: the transfer to your commercial partner is planned from the outset and set out in the contract, so you never depend on us.
Two things are essential for marketing a finished medicinal product: a marketing authorisation granted by the competent authority, and its ongoing maintenance throughout the product's life. Regulatory affairs covers everything needed to obtain the authorisation (or registration) and keep it valid over the long term.
We take on these tasks for you, with named people responsible rather than changing contacts.
You plan to bring your pharmaceutical products to the EU market but have no pharmaceutical company operating there.
Can you become the marketing authorisation holder for our product?
Yes. We meet all the requirements for a marketing authorisation holder in the EU. We apply for the marketing authorisation on your behalf and hold it on an interim basis. The exit is a standard procedure, not an exception. A&O does not act as distributor or sales organisation for the product; the transfer of the marketing authorisation to your commercial partner or your own distribution affiliate is planned from the outset and set out in the contract.
The approach has two stages:
Statutory roles: During the procedure and beyond, we provide the Stufenplanbeauftragter (German QPPV) under § 63a AMG, the Qualified Person (QP) under § 14 AMG and the Information Officer under § 74a AMG.
Once the marketing authorisation has been transferred to your commercial partner or distribution affiliate, we can continue to handle lifecycle management and the pharmacovigilance obligations under § 62 et seq. AMG. We also carry out the required EU batch certification and EU retesting. You decide the scope of our work.
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationTarget markets, procedure and timeframe. We tell you which route is fastest and what it will cost.
We review what is available and tell you plainly what is missing or should be clarified with the authority in advance.
We compile and submit the dossier, respond to questions from the authorities and manage the procedure.
We hold and maintain the marketing authorisation until it can be transferred to your commercial partner.
Typical starting points
You have no legal entity in the EEA, and therefore no one who could hold the marketing authorisation. Without this step, the product cannot reach the market at all.
It is your first dossier and you have no regulatory affairs department. You need someone who already knows the route, rather than learning it alongside development at considerable cost in time and money.
Variations, renewals and lifecycle maintenance are piling up while your own specialists work on new products. Maintenance is mandatory, but it ties up the same people.
You need the application under Regulation (EU) 536/2014, including the IMPD, and the trial start date is already set.
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.
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 analysis, specialist pharmacist in clinical pharmacy
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
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 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 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 studyWe will answer your questions in an initial consultation. Ute Hegener will take the time to go through them with you.
Book 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 matters 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 an EU company with all the regulatory obligations that entails. As soon as you are ready, the authorisations are transferred in an orderly way to the commercial partner you have chosen. Authorisation and building your commercial set-up can run in parallel, which saves considerable 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 choice. You keep control of the product and decide when it is transferred and to whom.
Yes. You do not get an anonymous ticket number but a named person responsible for your project. You know who you are talking to and can reach that person directly, including by phone.
Both. You can commission individual services such as strategic advice, a single submission or lifecycle management. You can equally combine regulatory affairs with manufacturing (§ 13 AMG) and analytical testing from one provider, if you prefer to have everything in one place.
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 authorisations throughout the product lifecycle.
After a confidential initial consultation, we agree the strategy and procedure with you and can move quickly into preparation. The exact timeframe depends on the product, the target market and the authorisation procedure. We make this clear before you commit to anything. You will usually hear back from us within one to two working days, with no obligation and in confidence.
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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.
