kaltwasser rechtsanwälte –
the law firm

// Scientific validation – with and without gold standard

// Differentiation between product & image advertising

// Mandatory information

// Advertising in the package leaflet / on the outer packaging

// Pre- & post-marketing

// Customer relationship systems (CRM) in the healthcare sector

We offer:

// Consulting

// Representation in warning letters and court proceedings (injunction, lawsuit)

// Training for employees on & offsite

// Price regulation under the AMNOG

// Early benefit assessment by the Federal Joint Committee (G-BA)

// Reimbursement amount negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV)

// Discount agreements

// Regional pharmaceutical contracts

// Prescription control by associations of statutory health insurance physicians, health insurance funds & review bodies

// Fixed amounts

// Therapy notes

// Prescription restrictions & exclusions

// aut idem rule

// Lead substance targets & quotas

// Medication catalog of the KBV

// Drug information system

// Performance audit

We offer:

// Consulting

// Representation vis-à-vis cost bearers, before (civil, social & administrative) courts & authorities (G-BA, GKV-SV, public procurement chambers)

// Authorization (original, hybrid medicinal products, generics, biosimilars)

// Labeling (outer packaging, containers, product information, package leaflet)

// distribution (distribution channels, co-promotion, co-marketing, co-distribution)

// Legal requirements for pricing

// In-house & contract manufacturing

// responsible persons (step-by-step plan & information officer)

// Manufacturing & wholesale authorization

// Delimitation of responsibility contracts

// Reimbursement (SGB V)

// Research & development contracts (see "Clinical studies")

// Drug safety (pharmacovigilance)

We offer:

// Consulting

// Representation before authorities & courts

// Training for employees on & offsite

// Classification (for apps & software or differentiation from medicinal products)

// Conformity assessment

// Placing on the market (CE marking)

// Product information (labeling & instructions for use)

// Contract manufacturing, distribution, contracts

// Liability

We offer:

// Consulting

// Representation before authorities & courts

// Training for employees on & offsite

// Cooperation with HCPs, medical facilities (outpatient & inpatient), pharmacies

// Cooperations, sponsoring, speaker contracts

// Anti-corruption law, 299a/b StGB & industry codes (FSA, AKG, BVMed, EFPIA...)

We offer:

// Consulting

// Preparation & implementation of SOPs

// Representation before courts & self-help organizations

// Training for employees on & offsite

// Research & development contracts

// Funding & cooperation agreements for ISS ("Investigator Sponsored Study" = IIS)

// Investigator contracts

// CRO contracts

// Manufacturing, labeling & reimbursement of investigational medicinal products

We offer:

// Consulting

// Representation before courts, (regulatory) authorities & ethics committees

// Product liability claims of patients for medicinal products & medical devices

// Claims for information, in particular for medicinal products according to § 84a AMG

// Product recalls

We offer:

// Consulting

// Representation vis-à-vis claimants (patients) & in court

// Training for employees on & offsite

// Professional law

// Effects of the Anti-Corruption Act

// Pharmacy operating regulations

// Multiple ownership & mail order

// Hospital supply

// Wholesale license

// Inspections

We offer:

// Consulting

// Representation vis-à-vis payers, before courts & authorities