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 ( about me ) 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
Medical devices
Food Supplementary Medicinal Products (FSMP)
Cosmetics
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)

BLOG

Brak wyników.

CONTACT

Head Office

PHARMAMED.PL Monika Korycińska-Matyaszewska
Regulatory Services

Okińskiego 6 m 59, Warsaw 02-115, Poland
+48 500 240 067
monika.korycinska@pharmamed.pl

Let’s talk

I hereby agree to have my personal data processed by PHARMAMED seated in Warsaw at Okińskiego 6 m 59.

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In a few words about me ...

Experienced consultant with a demonstrated history of working in the pharmaceutical industry. Skilled in Regualtory Affairs Requirements, Pharma Law, Generics, Medical Devices, Submissions, Post-authorization Maintenace, e-CTD, Serialization, R&D, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP). Strong business development professional graduated from Warsaw University of Technology. Familiar with most therapeutic areas.

Last position - Regualtory Affairs Department Manager at Fresenius Kabi Polska.

As a member of not one project team, I supported company projects from the registration site. At the pre-registration stage, my task was to provide expert advice on items or issues which would affect Regulatory and R&D project teams, I was developing optimization of registration strategies for selected in-house or license -developed products. In the case of in-house products, I supported R&D teams in preparing the right product development strategy and proper documentation and collecting the data required to prepare the registration dossier. I have been developing registration documentation for API and finished products in CTD formats. I carried out audits of product registration dossier both in-house and at licensors sites (Cipla Ltd, Lupin Ltd, Camlin Ltd, Cadila Healthcare Ltd., Belupo, SMB Laboratories SA, Rafarm S.A, Medochemie Ltd), indicating bottlenecks that could generate additional questions during registration. For the needs of the BU, I carried out regulatory assessments, provided guidance in areas of expertise.

In my work in registration, I faced challenges related to proper planning of submissions of applications preceded by preparatory pre-registration activities and activities that could not be predicted or planned in advance and resulted only during the course of the processes. In the registration phase, I was responsible for coordinating and answering questions to the registration authorities (MA applications, renewals and variations).

Call me and let's talk!