COMMITED TO YOUR SUCCESS
from concept to APPROVAL
Fast response
Time Matters
Guaranteed
Delivery Time
Flexibility
To Meet Individual Needs
ABOUT
My focus.
supporting our clients by providing them with
tailor made regulatory solutions
My values.
listen with commitment
talk to understand better
advise how to develop ideas and your business
My idea about regulatory service.
skills and knowledge perfected while working in the Pharma industry for the past 20 years () dedication to excellence and a wide range of experience gained from industry leaders understanding the importance of regulatory inteligence in Global Pharma business success.
THE REASON my offer is focuesed on specific requirements set by my clients and with application of Polish and EU law. In doubtful cases I rely on scientific basis.
MY OFFER includes full range of services from registration to maintenance of your medicinal products, medical devices or FSMP.
REGARDLESS of whether your company is just starting operations or has been operating on the market for years, you probably work very hard on developing modern medicines or medical devices dedicated to the treatment of human diseases.
PERHAPS your resources have already been maximally extended to meet rapidly growing requirements. And maybe the need to adapt to the upcoming legal changes has put a huge strain on your team and you are concentrating your efforts to meet deadlines,
I have a solution for you…
I believe.
I could handle with all Regulatory Affairs of your products, make you to go through complexity of regulatory processes, file applications, monitor your processes and contact Polish Agency in your name.
So, why couldn’t your company focus on the business
and let me take care about the rest?
I could be your local partner.
Your company is considering registration of a medicinal product, medical device or maybe FSMP? And you’re wondering about local partner in Poland that you could safely entrust your confidential information to. Why should I help your company? – Because I know and understand the requirements of regulators here. And also because my approach to cooperation arises from passion. I perform it from scratch and it is in the focus. I listen, talk, then advise.
My office is located in Warsaw close proximity to Polish Agency. All you have to do is empower me to the local representation and I will take care of the rest.
OFFER
Medicinal products
Pre-/Registration
-
Planning registration strategy taking into account legal elements
-
Reviewing the product registration possibilities with indication of the most optimal choice of a procedure
-
Audit of registration documentation in terms of meeting the registration requirements and readiness to start the registration procedure
-
Preparation of expert reports – Quality Overall Summary (Module 2.3)
-
Compilation of chemical and pharmaceutical part of dossier (Module 3)
-
Help in organizing and preparing pre-submission meeting in registration procedures
-
Preparing / translating Product Information (SmPC, PIL, Package Labels) acc. QRD templates
-
Preparing bridging reports with leaflet readability tests.
-
Conducting registration procedures: national, MRP, DCP
-
Filing NDA:
-
preparation of Module 1
-
submission to local Authorities
-
monitoring the course of registration process
-
active dialogue with Authorities
-
active support in preparation answers to questions emerging during the process course
-
Post-registration
-
Help in monitoring and assuring all regulatory processes (variation – all types, renewals; MA Holder changes, notifications, MA withdrawals
-
Planning strategy for post-registration variations
-
Filing variation:
-
help in compleating vaiation documentation
-
submission to local Authorities
-
monitoring the course of variation procedere/s
-
keeping active dialogue with local Authorities
-
active support in preparation of answers to questions emerging during the process
-
-
Preparing communication to local authorities in case of: product first market placement, temporary cessation and re-market placement on the market, exemption from sunset clause, annual fees
-
Re-formatting registration dossier to the format CTD/NeeS
-
Development and adjustment of Product Information (SmPC, PIL, Package Labels)
-
Verification of graphic designs of packaging and leaflets according to local requirements
Medical devices
-
Help in preparing Polish translation of Instruction for Use and Labeling
-
Reporting a medical device to local Authorities (URPL)
Food Supplementary Medicinal Products (FSMP)
-
Support in preparing Label translation
-
Notification to local Authority (GIS)
LINKS
BLOG
Brak wyników.
CONTACT
Head Office
PHARMAMED.PL Monika Korycińska-Matyaszewska
Regulatory Services