{"id":3365,"date":"2022-02-23T11:27:36","date_gmt":"2022-02-23T11:27:36","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3365"},"modified":"2022-10-28T09:53:59","modified_gmt":"2022-10-28T09:53:59","slug":"company-founding","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/company-founding\/","title":{"rendered":"Startups"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_fullwidth_image src=”https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-unternehmensgruendung-min.jpg” alt=”Unternehmensgr\u00fcndung” title_text=”Pharma Unternehmensgr\u00fcndung” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_margin=”||0px||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.17.3″ text_font=”||||||||” text_line_height=”2em” header_font=”Manrope|600|||||||” header_text_color=”#20292f” header_font_size=”26px” header_line_height=”1.3em” header_2_font=”Manrope|600||on|||||” header_2_text_color=”#193b7a” header_2_font_size=”14px” header_2_letter_spacing=”1px” header_2_line_height=”1.2em” header_3_font=”Rubik|500|||||||” header_3_font_size=”38px” header_3_line_height=”1.4em” custom_margin=”0px||0px||false|false” header_2_font_size_tablet=”42px” header_2_font_size_phone=”32px” header_2_font_size_last_edited=”off|desktop” header_3_font_size_tablet=”28px” header_3_font_size_phone=”20px” header_3_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

Establishment of a pharmaceutical company in Germany \/ EU \/ US<\/h2>\n

We establish your pharmaceutical company<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”0px||||false|false” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.1″ _module_preset=”default” text_font=”Manrope||||||||” text_text_color=”#6d7c90″ custom_margin=”0px||||false|false” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

When founding a pharmaceutical company <\/strong>in Germany, <\/strong>specifically, in the EU<\/strong>, or in the US, <\/strong>in general numerous steps, regulations, and legislation must be observed. Especially when placing drugs on the German market, the requirements to serve as pharmaceutical entrepreneur (pU)<\/strong> according to \u00a7 67 paragraph 1 of the German Drug Law (AMG)<\/strong> have to be fulfilled.<\/p>\n

The company must also appoint a step-by-step plan officer, in accordance with Section 63a of the AMG<\/strong><\/a>, who has the necessary reliability and expertise to carry out the activity. Furthermore, an information officer, according to \u00a7 74a AMG<\/strong> <\/a>with the legally required expertise and reliability must be notified. The following documents must be enclosed with the notification of the pharmaceutical company: a current excerpt from the commercial register, the nomination of the information and step-by-step plan officer (including proof of professional qualification, a certificate of good conduct of document type O, not older than 3 months, a copy of the policy on the required pharmaceutical liability insurance, information on the procurement of the medicinal products (e.g. contract manufacturer, co-distribution right, possibility of own production, etc.).<\/p>\n

A pharmaceutical company must comply with Good Manufacturing Practice (GMP<\/strong>) guidelines, the Arznemittelgesetz (AMG<\/strong>), and the Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV<\/strong>) and establish a quality management system (QMS)<\/strong><\/a>. The decisive factor is whether you and your company manufacture medicinal products yourself (manufacturer’s permit in accordance with \u00a7 13 AMG<\/strong>), only want to distribute medicinal products (\u00a7 52a AMG wholesale permit<\/strong>) or want to import medicinal products from third countries (import permit in accordance with \u00a7 72 AMG<\/strong>). The application at the competent authority for the respective permit has to me made before starting the activity. An import permit can only be granted if, analogous to the manufacturing permit, certain personnel and material requirements are fulfilled (described in more detail in \u00a7\u00a7 13-20a AMG<\/strong>).<\/p>\n

When placing medical devices<\/strong><\/a> on the market, on the other hand, requirements such as CE marking in accordance<\/strong> <\/a>with the General Safety and Performance Requirements for Medical Devices and the prescribed conformity assessment procedure must be fulfilled. Likewise, a QMS<\/strong> <\/a>must be in place and personnel functions, such as those of a medical device safety officer, must be assigned in accordance with the Medical Devices Act (MPG)<\/strong>.<\/p>\n

Likewise, in the case of food supplements<\/strong> <\/a>and cosmetics<\/strong><\/a>, the corresponding legal requirements must be met by the company.<\/p>\n

We support you with individual tasks such as the recruitment of personnel or obtaining official approvals\u2013 or we can manage the entire establishment of a company in Germany, in another EU country or in the US. Feel free to contact us!<\/p>\n

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We implement the steps of your company foundation for you:<\/h2>\n

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Business plan<\/strong>
Market analyses, strategy definition, determination of corporate identity, product categories, target groups, legal form, permits, financing, insurance, tax calculations, etc.<\/p>\n

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Authorities<\/strong>
Obtaining approvals, permits, staffing of pharmaceutical functions, relevant registrations<\/p>\n

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Establishment of the departments<\/strong>
Marketing, human resources, accounting\/taxes, purchasing, logistics, product approval, drug safety, medical\/scientific department, research and development, controlling, etc.<\/p>\n

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Set up infrastructure (warehousing and distribution logistics)<\/strong>
Set up production facilities, production coordination, etc.<\/p>\n

\u00a0<\/strong><\/p>\n

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Establishment of distribution channels<\/strong>
Sales via pharmacies, wholesalers, doctors etc.<\/p>\n

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Product portfolio creation<\/strong>
Brand concepts, trademark applications, patent applications, in-house developments, licensing, etc.<\/p>\n

\u00a0<\/strong><\/p>\n

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Product launch<\/strong>
Marketing, target groups, advertising, corporate identity<\/p>\n

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Establishment of a pharmaceutical company in Germany \/ EU \/ US We establish your pharmaceutical companyWhen founding a pharmaceutical company in Germany, specifically, in the EU, or in the US, in general numerous steps, regulations, and legislation must be observed. Especially when placing drugs on the German market, the requirements to serve as pharmaceutical entrepreneur […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"

[et_pb_section fb_built=\"1\" fullwidth=\"on\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_fullwidth_image src=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-unternehmensgruendung-min.jpg\" alt=\"Unternehmensgr\u00fcndung\" title_text=\"Pharma Unternehmensgr\u00fcndung\" _builder_version=\"4.11.4\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=\"1\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_row _builder_version=\"4.10.7\" custom_margin=\"||0px||false|false\" custom_padding=\"0px||0px||false|false\" locked=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_text _builder_version=\"4.13.1\" text_font=\"||||||||\" text_line_height=\"2em\" header_font=\"Manrope|600|||||||\" header_text_color=\"#20292f\" header_font_size=\"26px\" header_line_height=\"1.3em\" header_2_font=\"Manrope|600||on|||||\" header_2_text_color=\"#193b7a\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.2em\" header_3_font=\"Rubik|500|||||||\" header_3_font_size=\"38px\" header_3_line_height=\"1.4em\" custom_margin=\"0px||0px||false|false\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"]<\/p>

Gr\u00fcndung eines Pharmaunternehmens in Deutschland \/ der EU<\/h2>

Wir gr\u00fcnden Ihr Pharmaunternehmen<\/h1>

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Bei der Gr\u00fcndung eines Pharmaunternehmens in Deutschland<\/strong> bzw. in der EU <\/strong>m\u00fcssen zahlreiche Schritte<\/strong>, Regularien<\/strong> und Gesetzgebungen <\/strong>beachtet werden. Gerade beim Inverkehrbringen von Arzneimitteln<\/strong>\u00a0sind die Bedingungen eines pharmazeutischen Unternehmers (pU)<\/strong> gem\u00e4\u00df \u00a7 67 Absatz 1 Arzneimittelgesetz (AMG) zu erf\u00fcllen.<\/p>

Ebenfalls muss das Unternehmen einen Stufenplanbeauftragten gem\u00e4\u00df \u00a7 63a AMG<\/strong><\/a> benennen, der zur Aus\u00fcbung der T\u00e4tigkeit die erforderliche Zuverl\u00e4ssigkeit und Sachkenntnis besitzt. Ferner ist ein Informationsbeauftragter gem. \u00a7 74a AMG<\/strong><\/a> mit gesetzlich vorgeschriebener Sachkenntnis und Zuverl\u00e4ssigkeit zu melden. Der Anzeige des pharmazeutischen Unternehmers<\/strong>\u00a0m\u00fcssen folgende Unterlagen beigef\u00fcgt werden: ein aktueller Handelsregisterauszug<\/strong>, die Benennung<\/strong> des Informations- und Stufenplanbeauftragten<\/strong>, einschlie\u00dflich Nachweis der beruflichen Qualifikation<\/strong>, ein F\u00fchrungszeugnis <\/strong>der Belegart O, nicht \u00e4lter als 3 Monate, eine\u00a0Kopie<\/strong> der Police \u00fcber die erforderliche Pharmahaftpflichtversicherung<\/strong>, Angaben \u00fcber den Bezug der Arzneimittel<\/strong> (z. B. Lohnhersteller, Mitvertriebsrecht, evtl. eigene Herstellung etc.).<\/p>

Ein Pharmaunternehmen<\/strong> muss den Anforderungen des GMP-Leitfadens (Good Manufacturing Practice), <\/strong>des AMG sowie<\/strong>\u00a0der Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)<\/strong> entsprechen und ein Qualit\u00e4tsmanagementsystem (QMS)<\/strong><\/a> erstellen. Entscheidend ist, ob Sie mit Ihrem Unternehmen Arzneimittel selbst herstellen<\/strong> (Herstellerlaubnis gem. \u00a7 13 AMG<\/strong>), Arzneimittel nur vertreiben<\/strong> wollen (\u00a7 52a AMG Gro\u00dfhandelserlaubnis<\/strong>) oder Arzneimittel aus Drittl\u00e4ndern einf\u00fchren<\/strong> wollen (Einfuhrerlaubnis gem\u00e4\u00df \u00a7 72<\/strong> AMG).<\/strong> Die jeweilige Erlaubnis ist vor Aufnahme der T\u00e4tigkeit bei der zust\u00e4ndigen Beh\u00f6rde zu beantragen. Eine Einfuhrerlaubnis<\/strong> kann nur erteilt werden, wenn analog zur Herstellungserlaubnis bestimmte personelle und s\u00e4chliche Voraussetzungen erf\u00fcllt werden, die in den \u00a7\u00a7 13\u201320a AMG<\/strong> n\u00e4her bezeichnet sind.<\/p>

Beim Inverkehrbringen von Medizinprodukten<\/strong><\/a> hingegen m\u00fcssen Voraussetzungen wie die CE-Kennzeichnung<\/strong><\/a> gem\u00e4\u00df den Allgemeinen Sicherheits- und Leistungsanforderungen f\u00fcr Medizinprodukte und das vorgeschriebene Konformit\u00e4tsbewertungsverfahren erf\u00fcllt werden. Ebenfalls muss ein QMS<\/a><\/strong> vorliegen und personelle Funktionen wie der Medizinproduktesicherheitsbeauftragte m\u00fcssen nach dem Medizinproduktegesetz (MPG) vergeben sein.<\/p>

Ebenfalls m\u00fcssen bei Nahrungserg\u00e4nzungsmitteln <\/strong><\/a>sowie Kosmetika<\/a> <\/strong>entsprechende rechtliche Voraussetzungen<\/strong> im Unternehmen geschaffen und umgesetzt werden.<\/p>

Wir unterst\u00fctzen Sie bei Einzelaufgaben wie der Rekrutierung von Personal oder beh\u00f6rdlichen Genehmigungen \u2013 oder wir \u00fcbernehmen gleich die gesamte Unternehmensgr\u00fcndung in Deutschland oder in einem anderen EU-Land. Sprechen Sie uns gerne an!<\/strong><\/p>

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Wir setzen f\u00fcr Sie die Schritte Ihrer Unternehmensgr\u00fcndung um:<\/h2>

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Businessplan<\/strong>
Marktanalysen, Strategiefestlegung, Festlegung der Corporate Identity, Produktkategorien, Zielgruppen, Rechtsform, Genehmigungen, Finanzierungen, Versicherungen, Steuerkalkulationen etc.<\/p>

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" icon_placement=\"left\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p>

Beh\u00f6rden
<\/strong>Einholung der Genehmigungen, Erlaubnisse, Besetzung der Pharma-Funktionen, relevante Eintragungen<\/p>

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Aufbau der Abteilungen<\/strong>\u00a0
Marketing, Personal, Rechnungswesen\/Steuern, Einkauf, Logistik, Produktzulassung, Arzneimittelsicherheit, medizinisch-wissenschaftliche Abteilung, Forschung und Entwicklung, Controlling etc.<\/p>

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Aufbau der Infrastruktur<\/strong> (Lagerung und Vertriebslogistik<\/strong>)
Produktionsst\u00e4tten errichten, Produktionskoordination etc.<\/p>

\u00a0<\/strong><\/p>

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Aufbau der Vertriebswege
<\/strong>Verkauf \u00fcber Apotheken, Gro\u00dfhandel, \u00c4rzte etc.<\/p>

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Produktportfolio-Erstellung
<\/strong>Markenkonzepte, Markenanmeldungen, Patentanmeldungen, Eigenentwicklungen, Lizenzierungen etc.<\/p>

\u00a0<\/strong><\/p>

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\"1_2,1_2\" use_custom_gutter=\"on\" gutter_width=\"2\" make_equal=\"on\" admin_label=\"Services\" _builder_version=\"4.13.0\" max_width=\"80%\" custom_margin=\"0px||0px||false|false\" custom_padding=\"0px||40px||false|false\" use_custom_width=\"on\" width_unit=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" icon_placement=\"left\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" hover_enabled=\"0\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\" sticky_enabled=\"0\"]<\/p>

Produkteinf\u00fchrung
<\/strong>Marketing, Zielgruppen, Werbung, Corporate Identity<\/p>

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