LIFE SCIENCES & PHARMA

LIFE SCIENCES & PHARMA 2017-05-11T17:33:45+00:00

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