Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS SOLUTIONS PRODUCT EXPERTISE DRUG-DEVICE COMBINATIONS Product expertise DRUG-DEVICE COMBINATIONS Drug-device combination products associate a drug with a medical device, and hence bridge different regulatory frameworks (drug or device). Drug-device combinations can be single products comprised of several components – e.g. transdermal patches, drug-eluting stents – separate products packaged together – e.g. syrup with spoon – or products packaged separately but intended for use only with a specific counterpart – e.g. antitumor drug to be injected with a specific needle to target the tumor in the relevant organ, or insulin pumps designed only for specific insulin formulations. Determining the Primary Mode of Action (PMoA) of a product is of strategic importance – whether it will be regulated as a drug or a medical device. Decisions made during the early stages of product development have major impacts on the path to marketing in terms of cost and time. Regulatory definitions and classifications vary across markets, which imply to mix different approaches and timelines in the design of global development plans. Key challenges encompass: Product positioning and regulatory strategy Determining Primary Mode of Action (PMoA) Preclinical development, animal models and proof-of-principle study designs Clinical development plan and study designs, including human factor studies Risk and quality management Biological and clinical evaluation, including literature analysis Complex international registration pathways requiring expertise in both drugs and medical devices Bridge device and drug vigilances Life cycle and change management Market access strategy and value demonstration to payers VCLS Solutions Science-based, global product development strategy and planning Advise on product qualification and classification as well as product registration path Assist with claims positioning and determining Primary Mode of Action (PMoA) Advise on combination product co-development plan Prepare for/conduct international regulatory bodies Innovation Meetings (Notified Bodies, EMA, FDA) Develop roadmaps towards international regulatory approvals (EU, US, Australasia, South-America) Assist with preclinical and clinical development plans Tactical operations Interact with international regulatory bodies (Notified Bodies, EMA, FDA,) Develop risk analysis and risk management plan Submit international Clinical Trial Application Build/support implementation Quality Management System (QMS) and Good Manufacturing Practices (GMPs) Prepare product international regulatory dossiers (EU: CE mark Technical File; US: Request for Designation (RfD), 510k, PMA; Canada; Australasia; South-America), This could also lead to de novo applications on the device side and IND’s and NDA/BLA’s if determined to be a drug or biologic Build/support implementation vigilance system Assist with Post-marketing surveillance (PMS) Advise on labeling and advertising SOLUTIONS By Stage of Drug Development By Stage of Medical Device Development Product Expertise Industry Focused Therapeutic Areas Solutions for Switzerland Orphan Drugs VCLS COVID-19 Update PUBLICATION Medical Device Addressing The Impact of The EU Medical Devices Regulation on Combination Products An inter-regulatory and stakeholder workshop on combination products, organised by TOPRA and RAPS, was held in Brussels in November 2018.… EXPERTISE Regulatory Strategy & Submissions Design and implementation of global patient-centric regulatory strategies to ensure expedited product… Clinical Trial Operations Partner your way, we are your single contact for all activities towards… Vigilance From pre-market product safety to post-market surveillance and data analysis to meet… ALL PRODUCT EXPERTISE GET IN TOUCH --- Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d'Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Islands Poland Portugal Puerto Rico Qatar Rennes st Gregoire Romania Russian Federation Rwanda Réunion Saint Barthélémy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Sri Lanka State of Palestine Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria São Tomé and Príncipe Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu USA Minor Outlying Islands Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (USA) Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Select your country...* --- Search Engine Conference Referral Social Media (LinkedIn, Twitter) Webinar Neighborhood Event Neighborhood Website How did you hear about us ?* --- Biologic Drugs Cell, Gene and Tissue Therapy Chemical Drugs Classical Medical Device Combination Product Digital Medical Device E-Health/M-Health IVDs & CDx Microbiome-based Products Vaccines Other Product type...* *I have read and agreed to the Terms of Use and the Privacy Policy. 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