Lawyers focused
on regulated
products
Expertise in a particular area is a key for effective counsel.
Areas
Human Health
medicines
medical devices
dietary supplements
foods for particular nutritional uses
organic food
cosmetics
Healthcare
At what stage we can assist you?
01
Research
- We will conduct analyses regarding sector regulations, for ex. Good Clinical Practice.
- We will assist you in obtaining permissions for conducting research, as required by law.
- We will draft or verify a contract.
- We will seek resolution of a dispute concerning the research.
- We will take care of data flow compliance.
02
Marketing authorisation
- We will assist you in registration, notification and further documentation modifications.
- We will look after contacts with administrative authorities on your behalf.
- We will advise you what impact post-registration changes will have on distribution.
- We will support you in the process of portfolio acquisition.
- We will advise you on EAP type programmes.
03
Manufacturing
- We will conduct proceedings regarding obtaining or changing of a license.
- We will support you in the plant sale transaction (from a regulatory point of view).
- We will prepare you for an inspection.
- We will support you in discussions with administrative authorities.
- We will prepare analyses concerning manufacturing regulations, for ex. Good Manufacturing Practice.
04
Wholesale distribution
- We will advise you in the choice of the best distribution structure.
- We will assist you in obtaining or changing of a license.
- We will prepare you for an inspection.
- We will draw up templates of procedures, contracts with subcontractors, suppliers and clients.
- We will advise you in the scope of ZSMOPL, serialisation, Good Distribution Practice and other sector regulations.
- We will support you in the implementation of automation in compliance with sector regulations.
05
Pharmacies
- We will advise you how to open a pharmacy.
- We will support you in contract negotiations with agents, wholesale outlets and other entities.
- We will assist you in contacts with supervisory authorities.
- We will advise you in the matters regarding pharmacist’s professional responsibility.
05
Healthcare
- We will prepare documentation templates for a healthcare entity, doctor’s office or a veterinary clinic.
- We will advise you on patients’ data protection.
- We will assist you in crisis situations (for ex. a dispute with a patient).
- We will assist you in the implementation of telemedical devices and other innovations.
- We will advise you in the matters regarding allowed forms of providing information about services.
06
Marketing
- We will evaluate advertising materials.
- We will take care of communication with supervisory authorities and competitors.
- We will draft marketing and sponsorship contracts.
- We will advise you which marketing and trademarketing tools to choose.
07
Reimbursement
- We will assist you in market access strategy.
- We will advise you in the matters regarding risk sharing instruments.
- We will conduct reimbursement proceedings.
- We will assist you in contacts with the Ministry of Health and National Health Fund.
08
Price strategy
- We will support you in safe implementation of trade marketing tools.
- We will train your Sales department.
- We will draw up company regulations and internal procedures.
- We will negotiate a trade contract.
Modern Lawyers
We are lawyers who do not like wasting time.
We are convinced that legal analyses do not have to be incomprehensible and multi-page, and the contact with advisors should not be cumbersome and formalized.
More about usFind out what we can do for you.
Contact us!
MOYERS ARNAUDOW ŚWIĄDER KANCELARIA ADWOKACKO-RADCOWSKA SP.P.
ul. Wołoska 5, 02-675 Warszawa
show map