AVANTCORE has decades of expertise in Medicines Law and advises your company in all phases of drug development, research, manufacturing, and distribution. When necessary, we represent you in dealings with competitors and regulatory authorities.
Our services in pharmaceutical law include:
- Admission and registration: We will assist you in the process of market authorization or registration of your medicinal products with the responsible German authorities (PEI, BfArM, BVL) and the EMA. We will review the legality of conditions, withdrawal, or revocation orders and, if necessary, file appeals on your behalf to maintain the market presence of your preparations. If you do not wish to distribute your authorized preparations yourself or wish to distribute the product of another marketing authorization holder, we will design co-distribution agreements and co-marketing agreements for you.
- Manufacturing and import: We design contract manufacturing agreements, quality assurance agreements, responsibility delineation agreements, technical agreements, master service agreements, and other agreements for you. Contracts required for manufacture or importWe advise and represent you before the competent authorities if you require a manufacturing or import license or if your existing license is at risk. This also includes advising and, if necessary, dealing with authorities – including in court proceedings – in relation to Good Manufacturing Practice (GMP) requirements.Good Manufacturing Practice – Good Manufacturing Practice (GMP) concerning the manufacturing of medicinal products and active pharmaceutical ingredients. We advise you on compounding by contract manufacturers or pharmacies and on the necessary contracts for this purpose.
- Distribution: We create your contracts with partners for the distribution of medicinal products at all distribution stages. We advise you on compliance with Good Distribution Practice (Gross Domestic Product – Good Distribution Practice) and the Medicinal Products Pricing Regulation. We advise you on the requirements for pharmacy distribution and on the limitations of direct sales of medicinal products. We advise and represent you in dealings with the competent authorities if you require a wholesale license or if your existing license is at risk.
- Clinical trialWe advise you on your clinical trials and draft study site agreements, CRO agreements, agreements for the support of IITs, and other contracts required for conducting clinical trials by industry or academia, and assist you in concluding them. We will guide you through the approval process with the competent authorities and the ethics committee. With our support, you will adhere to the principles of Good Clinical Practice (Google Cloud Platform – Good Clinical Practice).
- Pharmacovigilance: We help you with your observation, documentation, and reporting obligations in accordance with the requirements of the following, for all reports relevant to drug safety and proactively in advance of them GVP (Good Vigilance Practice). We also advise and represent you in dealings with authorities regarding whether and, if applicable, what response obligations exist, particularly with regard to a recall.
- Advertising and information: We advise you on the design and conceptualization of your medicinal product advertising and check it for compliance with the German Act on the Advertising of Medicinal Products (HWG) and the Act Against Unfair Competition (UWG). We file protective briefs on your behalf and represent you in competition law disputes with competitors and competition associations who wish to prevent your advertising.
- Substances of Human Origin (SoHO): We advise your blood donation facility, collection facility, or tissue facility on all operational issues of transfusion law (TFG), transplant law (TPG), and drug law (AMG). We draft the contracts required for cooperation with partners and support you with authorities in obtaining and maintaining your permits (permit for the procurement of tissues and laboratory investigations according to § 20b AMG; permit for tissue preparations according to § 20c AMG; permit for blood donation facilities). We represent blood donation and collection facilities if they and their physicians are sued for alleged medical malpractice in connection with the procurement of blood components or tissues/cells. We prepare you for the requirements of the SoHO Regulation.
- Surveillance: We advise and represent you in all official supervision activities concerning the manufacture, trade, or clinical testing of medicinal products.
- Pricing and reimbursement: We advise you regarding the discounting of your preparations according to SGB V and their reimbursement in statutory health insurance (GKV).
- Pharmaceutical criminal law: We advise and represent you – if necessary, with the involvement of another criminal defense attorney – in pharmaceutical law investigations.
Our services in pharmaceutical law are closely integrated with those in Data Protection Law, Product Liability Law and Competition Law.
EN 
DE