Regulatory affairs

Marketing authorisation dossiers, variations and communication with BfArM, PEI and EMA.

22 providers with evidence Sourced from law and guidelines · as of 10.11.2026 View providers

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In brief

Regulatory affairs covers all the tasks a company performs to obtain a marketing authorisation for a medicinal product and to maintain it over the product’s entire life. This includes compiling the marketing authorisation dossier, choosing the right procedure, communicating with the authorities and, later on, notifying or applying for every change that affects the terms of the authorisation. In Germany, a finished medicinal product may only be placed on the market if it has been authorised by the competent federal higher authority or through the centralised procedure of the European Union.

What is submitted

A dossier in Common Technical Document format with five modules, submitted electronically as eCTD.

Which routes exist

Centralised via the EMA, decentralised, mutual recognition or purely national.

Who is responsible in Germany

The Federal Institute for Drugs and Medical Devices (BfArM); for vaccines, blood products, allergens, advanced therapy medicinal products and some other groups, the Paul-Ehrlich-Institut.

What comes after authorisation

Under the Variations Regulation, changes are classified as Type IA, IB or II and notified or applied for accordingly.

The Common Technical Document (CTD) is the internationally agreed structure defined by ICH. Module 1 contains the regional administrative information, in the EU for example the application form, the summary of product characteristics, the package leaflet and the labelling, and is not harmonised. Module 2 summarises the other modules in overviews and summaries, Module 3 describes the pharmaceutical quality, Module 4 contains the non-clinical study reports and Module 5 the clinical study reports. Modules 2 to 5 have the same structure in all ICH regions.

When you need this

The obvious occasion is the first marketing authorisation application. Companies that have mainly done development work rarely have a team that can write a complete dossier, define the procedural strategy and answer the authorities’ questions within the set deadlines. The need is just as common during routine operations, however, because every change to manufacturing, testing, suppliers or product information has to be assessed, classified and notified. With a larger portfolio this becomes a steady workload that can be outsourced in whole or in part.

Other occasions are extending an authorisation to further Member States, taking over authorisations when acquiring a product, and moving to a different contract manufacturer.

Legal basis and rules

Directive 2001/83/EC

The Community code relating to medicinal products for human use. It sets out the requirements for the marketing authorisation application as well as the mutual recognition procedure and the decentralised procedure, in which Member States take part under the lead of a reference Member State.

Regulation (EC) No 726/2004

Governs the centralised procedure. The EMA assesses the application scientifically, and the European Commission grants a marketing authorisation that is valid throughout the EU as well as in Iceland, Liechtenstein and Norway. This route is mandatory for, among others, biotechnology products, advanced therapy medicinal products, orphan medicinal products and new active substances for certain diseases such as cancer, diabetes or viral infections.

German Medicines Act (Arzneimittelgesetz, AMG)

Transposes the Directive into German law. It contains the authorisation requirement (§ 21), the national procedure and the rules for mutual recognition and the decentralised procedure (§ 25b). Under § 77, the competent authority is the BfArM or the Paul-Ehrlich-Institut.

Regulation (EC) No 1234/2008

The Variations Regulation governs changes to marketing authorisations. It was amended by Delegated Regulation (EU) 2024/1701 and has applied in this version since 1 January 2025, including to purely nationally authorised medicinal products.

Variations guidelines (C/2025/5045)

The Commission’s new guidelines assign the individual changes to the categories and describe the procedures. They apply to submissions from 15 January 2026 and replace the 2013 guidelines.

ICH M4 and eCTD

ICH M4 defines the structure of the CTD. In the European procedures, and in Germany also in the purely national procedure, submissions are made electronically in eCTD format.

The choice of procedure follows a simple logic. If the medicinal product falls within the mandatory scope of the centralised procedure, there is no choice. Otherwise, a company can apply for an authorisation in a single country, apply in several Member States at once with identical documents in the decentralised procedure, or extend an existing national authorisation to further countries in the mutual recognition procedure. In these multi-country procedures, the reference Member State prepares the assessment report and the drafts of the summary of product characteristics, labelling and package leaflet, and the other Member States recognise the outcome unless they see a serious risk to public health.

Three categories of changes

Type IA changes have no or only minimal impact. They may be implemented without prior review but must be notified within twelve months, usually collected in an annual report, and certain cases must be notified immediately after implementation. Type IB changes are notified before implementation, after which the holder waits 30 days to see whether the authority accepts the notification. Type II changes require approval before they are implemented. Which category applies is determined by the annex to the guidelines.

How the work is organised

A service provider can support the entire process or take on individual parts of it:

Strategy and gap analysis

Assessment of which procedure is suitable, in which countries the product should be authorised and which data are still missing for the dossier.

Preparing the dossier

Writing or revising Modules 1 to 3 and the summaries in Module 2, often in coordination with the manufacturer, the testing laboratory and the authors of the study reports.

Submission

Compilation in eCTD format, technical validation and submission via the authorities’ portals.

Assessment phase

Answering the authorities’ questions within the deadlines of the respective procedure and agreeing the product information.

Post-authorisation maintenance

Assessment and classification of every change, annual reports for Type IA changes, applications for Type IB and II, and ongoing updating of the dossier.

Integrate the regulatory assessment into your change management so that, before any change is implemented, it is clear whether a notification or an approval is required, and agree who maintains the current version of the dossier.

What to look for when choosing a provider

Regulatory service providers differ mainly in the procedures, product groups and authorities they have experience with. These questions help when comparing them:

Questions to ask the provider

Which procedures has the provider handled itself: centralised, decentralised, mutual recognition or national?

Does it have experience with your product group, for example generics, biologics or medicinal products that fall under the Paul-Ehrlich-Institut?

Who writes the quality module, and how closely does the provider work with your manufacturer?

Does it already work according to the variations guidelines that have applied since 15 January 2026?

Which software does it use for eCTD, and will you receive the complete lifecycle at the end?

How will it be integrated into your change management, and who decides on the classification?

Frequently asked questions

When is the centralised procedure mandatory? +

Among others, for biotechnology products, advanced therapy medicinal products, products designated as orphan medicinal products, and new active substances for the treatment of cancer, diabetes, neurodegenerative diseases, HIV/AIDS, autoimmune diseases and viral diseases. For other medicinal products it can be used voluntarily under certain conditions.

What is the difference between the decentralised procedure and mutual recognition? +

In the decentralised procedure, the medicinal product is not yet authorised in any Member State, and all participating states assess it at the same time. In mutual recognition, an authorisation already exists in one Member State, and the other states recognise its assessment.

Do the rules on variations also apply to nationally authorised medicinal products? +

Yes, the Variations Regulation also covers purely national authorisations. The AMG excludes only a few groups, for example certain older homeopathic medicinal products and blood products, for which the national notification of changes still applies.

Will the reform of EU pharmaceutical law change the rules? +

The EU has launched a comprehensive reform of its pharmaceutical legislation, most of whose provisions are only to apply after a transition period. Until then the rules described here apply, but for long-term planning you should check the current status with your service provider.

Sources

Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.

Providers

companies name this service on their own website.

A&O Pharma GmbH Efringen-Kirchen
AGON Pharma GmbH Wendlingen Am Neckar
Actrevo GmbH Hamburg-Altstadt
Allucent (DE) GmbH Köln
Artesan Pharma GmbH & Co. KG Lüchow (wendland)
Astrum CRO Germany GmbH Ismaning

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Providers

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Company	Location	EvidenceQuote from the company’s website (German)	Credentials
A&O Pharma GmbH A&O Pharma GmbH, based in Efringen-Kirchen with sites in Itzehoe and Lörrach, provides service support to pharmaceutical companies, including batch certification by Qualified Persons, regulatory affairs, GMP consulting and GMP-certified analytics.	Efringen-Kirchen	Evidenced „Von der Zulassungsstrategie über IMP- und MAA-Dossiererstellung, der Beantragung des Zulassungsverfahren bis hin zum Life Cycle Management“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
AGON Pharma GmbH AGON Pharma GmbH, based in Wendlingen, provides contract analytical services for batch release testing, stability studies in climatic chambers, and method validation and marketing authorisation support for medicinal products of other companies.	Wendlingen Am Neckar Baden-Württemberg	Evidenced „Benefit from over 30 years of experience in preparing and submitting national and international marketing authorisation documentation“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Actrevo GmbH actrevo GmbH, based in Hamburg, provides pharmaceutical companies with EU marketing authorisation procedures, import services and Qualified Person batch certification. The company also markets its own medicinal products, including Alltrevo, Hialurom and Rafaject.	Hamburg-Altstadt Hamburg	Evidenced „Zulassungsverfahren in Kunden- oder eigenem Namen. Dossiers vollständig auf EU-Standard inklusive GMP-Beratung.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Allucent (DE) GmbH Allucent (DE) GmbH, based in Cologne, is a contract research organisation (CRO) serving small and medium-sized biopharmaceutical companies. It offers clinical development, pharmacovigilance and regulatory consulting.	Köln	Evidenced „Its integrated services span regulatory and drug development consulting, clinical pharmacology, quantitative sciences, clinical development operations, and safety and pharmacovigilance.“ Source · 10 Nov 2026 ↗
Artesan Pharma GmbH & Co. KG	Lüchow (wendland) Niedersachsen	Evidenced „Wir betreuen die Erstellung ihres Zulassungsdossiers im eCTD-Format einschließlich der entsprechenden Sachverständigengutachten und Formblätter für humane und veterinäre Arzneimittel sowie Medizinprodukte.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Astrum CRO Germany GmbH Astrum CRO GmbH in Ismaning is part of the Astrum Group, headquartered in Madrid. The company provides clinical trials from Phase I to Phase IV, along with advisory services on development strategy and dealings with regulatory authorities.	Ismaning	Evidenced „preparation and support for EMA, FDA, and EU authority advice meetings, ensuring alignment from the outset“ Source · 10 Nov 2026 ↗
BBT Biotech GmbH	Baesweiler Nordrhein-Westfalen	Evidenced „die Leistungen unserer Regulatory-Affairs-Abteilung bei der Erstellung einzelner Dokumente oder kompletter Teile der Zulassungsunterlagen“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
ClinChoice GmbH ClinChoice GmbH, based in Aachen, is part of a US-based full-service CRO headquartered in Horsham. The company supports pharmaceutical and biotech firms with clinical trials, marketing authorisation and quality management.	Aachen	Evidenced „Navigate the regulatory landscape seamlessly with our global and local expertise, providing timely strategic advice to facilitate product development“ Source · 10 Nov 2026 ↗
Dopiopharm GmbH Dopiopharm GmbH, based in Bad Salzungen, provides quality management and regulatory consulting for medicinal products, particularly narcotic drugs and medicinal cannabis, and also markets its own cannabis products.	Bad Salzungen Thüringen	Evidenced „Durchführung von pharmazierechtlichen Anträgen“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Flavine Europe GmbH Flavine Europe GmbH, based in München, brokers active pharmaceutical ingredients and finished medicinal products and offers laboratory testing in Marseille, regulatory support for manufacturers' dossiers, and logistics with cGMP-compliant warehousing.	München Bayern	Evidenced „Compile and prepare electronic files in eCTD format in support of master files (DMF, VMF, and EDMF/ASMF) as well as CEP/COS“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
KLIFO GmbH KLIFO GmbH, based in Munich, is a consultancy for drug development that also provides clinical trial supply. It supports pharmaceutical and biotechnology companies on strategic matters and handles the packaging, labelling, storage and distribution of trial medication.	München	Evidenced „KLIFO Advisory provides experienced guidance from early drug development to market.“ Source · 10 Nov 2026 ↗
Linical Europe GmbH Linical Europe GmbH, based in Frankfurt, is part of the global CRO Linical and provides clinical contract research, project management and regulatory affairs consultancy to biopharmaceutical companies.	Frankfurt	Evidenced „Linical's Regulatory Affairs team provides global expertise and resources to help with regulatory strategy, meetings, filings.“ Source · 10 Nov 2026 ↗
Lyomark Pharma GmbH Lyomark Pharma GmbH, based in Oberhaching near Munich, manufactures lyophilised and liquid sterile products, predominantly for the hospital market. The company also prepares marketing authorisation dossiers and periodic reports.	Oberhaching Bayern	Evidenced „Neben der Zurverfügungstellung der Dossiers unserer Produkte und der darauf basierenden Einreichung von Zulassungen sind auch folgende weitere Dienstleistungen erhältlich“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Mediconomics GmbH Mediconomics GmbH, based in Hannover, is an independent contract research organisation (CRO) providing clinical trial services, regulatory affairs, data management and pharmacovigilance to pharmaceutical and biotechnology companies.	Hannover	Evidenced „Ob es sich um eine klinische Studie oder ein Arzneimittel handelt – wir decken alle Bereiche für Zulassungen ab.“ Source · 10 Nov 2026 ↗
Midas Pharma GmbH Midas Pharma GmbH, based in Ingelheim am Rhein, is a medium-sized pharmaceutical company that develops and manufactures active pharmaceutical ingredients and intermediates on a contract basis. It also offers regulatory and quality services.	Ingelheim Am Rhein Rheinland-Pfalz	Evidenced „Regulatory services – CMC section or full ASMF“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Mikle-Pharm GmbH Mikle-Pharm GmbH, based in Landau in der Pfalz, advises pharmaceutical companies on regulatory affairs, marketing authorisation dossiers and project evaluation across the entire medicinal product lifecycle.	Landau In Der Pfalz Rheinland-Pfalz	Evidenced „compilation of application dossiers, submission, procedure management Agency communication, follow-up Scientific Advice SA, Clinical Trial Application CTA, Marketing Authorisation Application MAA“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
PROMEDIPHARM GmbH PROMEDIPHARM GmbH in Bensheim has been an independent service provider for pharmaceutical development and marketing authorisation since 1994. The company supports production and batch certification at contract manufacturers, as well as quality systems and regulatory inspections.	Bensheim Hessen	Evidenced „With regard to regulatory affairs we develop strategies for your product and compile or maintain your dossiers.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Symbio Clinical Research GmbH Symbio Clinical Research GmbH in Münster is part of the Symbio Group, a CRO for clinical trials in dermatology, aesthetics, gastroenterology and inflammatory diseases.	Münster	Evidenced „We offer a variety of regulatory services tailored to your needs and supported by a team of regulatory experts“ Source · 10 Nov 2026 ↗
TentaConsult Pharma & Med GmbH TentaConsult Pharma & Med GmbH, based in Münster with a site in Planegg, advises life sciences companies on regulatory affairs, quality management and pharmacovigilance. Its services also include the external assumption of the Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) roles.	Muenster Nordrhein-Westfalen	Evidenced „Regulatory Affairs, Qualitätsmanagement, Vigilanz sowie die Begleitung von Arzneimitteln, Medizinprodukten, Kombinationsprodukten“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Transo Pharm Handels GmbH Transo-Pharm Handels-GmbH in Siek distributes pharmaceutical active ingredients worldwide, offering sourcing, qualification of active ingredient manufacturers, GMP-compliant storage and regulatory support such as the preparation of Drug Master Files.	Siek Schleswig-Holstein	Evidenced „DMF-Erstellung und Registrierungen“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
acromion GmbH acromion GmbH, based in Frechen near Cologne, is an independent CRO for clinical trials from Phase I to Phase IV and for non-interventional studies, offering biometrics, data management, monitoring and marketing authorisation support.	Frechen	Evidenced „Our team of regulatory experts prepares – regardless of whether a CTIS, a conventional or an online application is desired – the required packages and reviews (QC) all application documents thoroughly“ Source · 10 Nov 2026 ↗
analyze & realize GmbH analyze & realize GmbH, based in Berlin, advises manufacturers of natural health products on marketing authorisation dossiers in Europe and conducts clinical studies. Founded in 2001, the company employs around 40 staff and operates its own study centre.	Berlin	Evidenced „the compilation of dossiers for market compliance in Europe and the performance of clinical studies according to local and international requirements“ Source · 10 Nov 2026 ↗

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