PATZAK + PARTNER

Regulatory Affairs + Intellectual Property + Beyond In Life Science

About.

WHO WE ARE.

Dr. Ulrich Patzak

Ulrich is a qualified Pharmacist and European Patent Attorney, with more than 25 years of experience in the pharmaceutical industry. Ulrich holds the European Patent Litigation Certificate and has been privileged to be a visiting lecturer at Rheinische Wilhelms University Bonn for intellectual property aspects of pharmaceutical law since 2014.

Ulrich has extensive experience as an employee of multinational organizations, as patent attorney in a widely recognised European patent law firm and for more than 10 years as a consultant and service provider for numerous international pharmaceutical companies.

Ulrich specialises in Regulatory Affairs and Intellectual Property for pharmaceutical products. Based on his breadth of qualifications, his focus is as an integrated service and consultancy provider.

Ulrich has extensive experience of working with a network of partners specialized in different aspects of pharmaceutical product development and life cycle. In a team with other specialists as appropriate, a comprehensive service is provided to the client. This network of professionals is available to provide the required expertise for your project.

About.

WHO WE ARE.

Cornelia Wagner

Cornelia Wagner is a qualified pharmacist with more than 25 years of experience in the pharmaceutical industry.

Cornelia gained extensive experience in small privately owned companies, mid sized contract manufacturers as well as in multinational organizations. She worked in Japan headquatered companies for more than 10 years.

She headed the Contract Manufacturing, Regulatory Affairs (CMC), Customer Service and International Business Development departments in the various companies.

From her broad experience, she has specialised in international business development for the last 10 years. This included the in-licensing of products as well as the out-licensing, sale and transfer of products.

Through various projects in the Europe, Middle East and Africa regions, she built up a broad network and gained many insights into country-specific requirements.

Service.

WHAT WE DO.

Within Patzak+Partner, during more than 10 years of consultancy service, clients have repeatedly entrusted us with further projects. We are proud of this trust in the delivery of our reliable services. The descriptions of projects below give you an overview of the expertise in Regulatory Affairs, Intellectual Property and Commercial Development.

REGULATORY AFFAIRS.

The experts of Patzak+Partner have extensive experience in the development and life cycle management of pharmaceutical products. They have broad international experience including management of global projects. A special focus is, besides Europe, the Asia region including China and Japan as well as Middle East and North Africa. Patzak+Partner worked on the development of innovative new chemical entities, anti-body compounds and combination products. Patzak+Partner has first-hand experience in all kinds of European marketing authorization procedures and authority advice procedures.

The therapeutic areas and examples of the projects give an overview of the work for clients.

Therapeutic areas

  • Dermatology
  • Gastroenterology
  • Infection
  • Inflammation
  • Ophthalmology
  • Oncology
  • Thrombosis
  • Transplantation
  • Urology

Examples of projects

  • Development lead oncology new chemical entity
  • Development antibody
  • Development fixed combination medicinal products
  • Development phytomedicine

  • Marketing authorisation applications EU/EEA and beyond
  • Variations for new indications EU/EEA and beyond
  • Scientific advice with EU/EEA agencies
  • Qualified Person for Pharmacovigilance (PV)
  • Authority inspections for PV and Quality Assurance (QA)
  • Due diligence
  • Regulatory affairs expertise for IPO

Service.

INTELLECTUAL PROPERTY.

Patzak+Partner is engaged in all aspects of intellectual property for pharmaceutical products, with a focus on patents, Supplementary Protection Certificates (SPC) and Regulatory Data Protection (RDP). The experience in both the patent area and in regulatory affairs was of important value in several successful litigation cases for pharmaceutical products.
EXAMPLES OF PROJECTS
  • Competitor landscape analysis development phase
  • Life cycle management analysis
  • Generic entry monitoring
  • Expert opinion on RDP, orphan exclusivity, patents, SPC
  • RDP litigation
  • Patent litigation
  • Settlement agreements in nullity and infringement cases
  • Patent expertise for IPO

Service.

WHAT WE DO.

COMMERCIAL DEVELOPMENT.
Due to the breadth of their experience, the experts of Patzak+Partner have been requested to support clients with commercial development activities. These activities spanned from the development of new indications or formulations to licencing and acquisition deals.
TEAM LEAD DEVELOPMENT PHARMACEUTICAL PRODUCTS
TEAM LEAD DIVESTMENT OF ASSETS
TEAM LEAD TRANSITION OF ASSETS
TEAM LEAD IN-AND OUT-LICENSING OF ASSETS
MANAGEMENT OF PHARMACEUTICAL COMPANY

Contact.

LET’S TALK.

The basis for the services of Patzak+Partner are confidence and professionalism. We are looking forward to offering our services for the implementation of your projects.