Delia Belciu is a leading expert in the life sciences field who talk the industry language and understand your business.
DB Law Office offers assistance on a wide range of regulatory matters in the Life Sciences and Pharmaceutical field, such as:
pricing
claw-back
distribution mechanisms
parallel imports
refusal to supply
public service obligation
good distribution practices
marketing authorization aspects
pharmacovigilance aspects
advertising and promotion of medical products, medical devices, food supplements, food products, cosmetics
labeling and packaging of medical products, medical devices, food supplements, food products, cosmetics
donations, sponsorship of medicinal products and medical devices
samples
clinical trials
disclosure of expenses
ethics compliance issues
hospitality
conflict of interests and incompatibilities of healthcare professionals
anti-corruption aspects
reimbursement
regulatory aspects regarding medical products, medical devices, food supplements, food products, cosmetics
regulatory aspects regarding medical services, e.g. dialysis, radiotherapy, psychology, dental care, etc
general terms of business
drafting, review and negotiation of license, supply, clinical trials, donations, sponsorship of medicinal products and medical devices, non disclosure agreements
liability of healthcare professionals
legal changes in the healthcare, medical devices, food supplements, food products, cosmetics field
assistance in front of the National Health Insurance House, the local Health Insurance Houses, the Ministry of Health, The National Agency for Medicines and Medical Devices, The National Institute of Research and Development for Food Bioresources
litigating on various aspects related to healthcare matters
arbitrations in front of the Arbitration Commission before the National Health Insurance House regarding the reimbursement of medical services provided by healthcare providers, etc.
day to day assistance