Companies and institutions in these industries operate in a highly regulated market. Thanks to the many years of experience of our team, AVANTCORE offers specialized and comprehensive solution-oriented consultancy in all phases of product development, marketing and all distribution levels. We also represent our clients in disputes with competitors or the authorities.
Pharmaceuticals
- Regulatory Advice and Representation: We consult our clients on all regulatory issues relating to your medicinal products and help you to avoid disputes with competitors or authorities. If necessary, we also represent you in disputes with your competitors or authorities and challenge their regulatory actions. Our regulatory advice covers all aspects of clinical trials of medicinal products in accordance with Good Clinical Practice (GCP), their manufacture and import in accordance with Good Manufacturing Practice (GMP), their distribution by pharmaceutical companies and wholesalers in accordance with Good Distribution Practice (GDP) and their distribution by pharmacies, as well as pharmacovigilance in accordance with Good Vigilance Practice (GVP). We also advise and represent you in marketing authorization and registration procedures for your medicinal products. This includes special product groups such as biosimilars, generics, advanced therapy medicinal products (ATMPs) or orphan drugs.
- Substances of Human Origin (SoHO): We advise on all aspects of transfusion and transplantation law relevant to the operation of your facilities (blood donation, collection and tissue establishments) and the quality and safety of your products. We draft and negotiate your contracts in this area and prepare you for the requirements of the SoHO Regulation. If blood donation or collection centers are sued by donors for alleged medical malpractice in connection with the collection of blood components or tissues/cells, we will work for the institution and its physicians to defend them against the claim. Verträge und bereiten Sie auf die Anforderungen der SoHO-Verordnung vor. Werden Blutspende- oder Entnahmeeinrichtungen von Spendern wegen eines vermeintlichen Behandlungsfehlers im Zusammenhang mit der Gewinnung von Blutbestandteilen oder Geweben/Zellen in Anspruch genommen, so werden wie für die Einrichtung und ihre Ärzte zur Anspruchsabwehr tätig.
- Pharmaceutical contracts: We draft and negotiate your commercial and regulatory contracts with national and international partners for clinical trials (e.g., clinical trial site agreements, CRO contracts, investigator-initiated trial (IIT) support contracts), your contract manufacturing agreements for investigational drugs and commercial products with technical agreements, and your distribution agreements.
Medical devices
- Conformity assessment and compliance of the actors: We advise you specifically with regard to your function as an economic operator on the regulatory requirements of the EU Medical Device Regulation (MDR) and the applicable implementing rules. We advise you on corrective actions in the event of incidents and represent you in dealings with the authorities during inspections. We support you in the conformity assessment procedure.
- Contract law: We draft, check and negotiate your distribution and regulatory agreements for medical devices, whether you are a manufacturer, importer, distributor or other economic operator.
Life Sciences
- Research and development: We advise our clients at all phases of research and development of drugs and medical devices, including the management of your intellectual property. For this purpose, we draft license agreements, contracts for contract research and research collaborations, and material transfer agreements (MTA) for you.
- IP strategies and know-how protection: We can advise you on licensing and protecting your intellectual property and know-how. To protect your trade secrets, we can draft your non-disclosure agreements (NDA) and advise you on your company's internal secrecy measures.
Cross-industry services at the interface:
- Data protection Data protection Data privacy is an all-encompassing issue that is particularly relevant to the processing of health data in the pharmaceutical, medical device, and life sciences industries. We advise you on the requirements of the General Data Protection Regulation (GDPR) and other relevant data protection laws. In particular, we draft your data processing contracts (joint controller agreements, processor agreements).
- Advertising and compliance: We advise you on all aspects of advertising your medicinal products and medical devices and defend you in the event of complaints from competitors, associations or authorities. We help you structure your relationships with hospitals and physicians to ensure compliance with healthcare regulations.
- Product safety and liability: We can help you manage liability issues, particularly with respect to the safety requirements of your products, and defend against claims against you.
Our pharmaceutical, medical device, and life sciences experts work closely with you to develop customized solutions that meet both your business objectives and regulatory requirements.
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