Pharma Resources

Come in and get to know Pharma Resources. We appreciate your interest.

Welcome to Pharma Resources

For over 20 years we assist and support our customers in the healthcare industry in bringing pharmaceuticals and medical devices in the market. For this, we provide our customers with the resources available, you need to move on to your personal goals at the most - and that non-bureaucracy, authentic and professional.

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Our History

Pharma Resources – that is the profitable combination of the company's 20-year history and 25 years of the partner's market experience in the areas of service and contract manufacturing for pharmaceuticals, medical products and biotechnology.

_1991 to 1998 – From raw-materials broker to a service provider for drug marketing authorisation

Pharma Resources was founded in 1991 by the merchant Peter Franck in Ahrensburg, near Hamburg. At the time of its foundation, the sole business activity performed by Pharma Resources was the trade in pharmaceutical raw materials. In the following years the company established services for marketing authorisations as additional line of business under the Management of Dr. Gabriele Schluttig as a supplement to dealing with raw materials. The business developed successfully; nevertheless, in 1998, Peter Franck decided for personal reasons to sell his company to the Swiss-based Dolder AG.

_1998 to 2002 – As a service provider for marketing authorisations in Switzerland

 

With the strategic idea to assure the existing trade business with our own dossier and marketing authorisations business, the Swiss-based company Dolder AG had acquired Pharma Resources in 1998. However, in the following years, the strategy proved to be a disappointment: because Switzerland was not a member of the EU, the Dolder AG was not able to organise marketing authorisations for the European market from there; at the same time, export certificates prepared in Switzerland were not recognised. Due to that, there was no future for Pharma Resources in Switzerland.

Our History

_2002 to 2010 – In the hands of two experts back in Germany

After Switzerland proved to be a disadvantageous location for the service business with marketing authorisations, Pharma Resources was taken over in a management buy out (already four years after the takeover by the Dolder AG) by the two executives Dr. Gabriele Schluttig and Hermann Kopf. The company's main office was relocated once again to Germany, this time to Dreieich near Frankfurt am Main. As of 2002, with several interesting development projects,  Pharma Resources succeeded in gaining renowned customers for the service business and laying a broad cornerstone for the company's success in the years that followed.

_2010 to the present

 

As a well-established service company with product-based unique selling points on the European health-care market, the company Pharma Resources changed hands on 1 January 2011, passing to the ownership of the entrepreneur family Lürig. Therefore, the 20-year success story of Pharma Resources merged with 25 years of personal market experience brought to bear by the new partner, Detlef Lürig. Associated with the change in ownership, the company's main office was relocated once again: in 2011, the company moved from Dreieich near Frankfurt am Main to Hameln an der Weser.

Regulatory Affairs Service

To enable you to rely on the substance brought forth for marketing authorisation in your name, we will co-ordinate the entire marketing authorisation process.

  • Projectmanagement
  • Regulatory & Due - Diligence Consulting
  • Execution of national, MR-, DC- and centralised procedures
  • Support by the treatment of marketing authorisation applications
  • Answering of deficiency letters

  • Maintenance ,support and optimisation of your marketing authorisations 
  • National variations and EU variation procedures
  • Updates of marketing authorisation documentation
  • Re-formatting from NTA to CTD
  • Readability tests

 

 

Clinical & Medical Affairs Service

The medical-scientific care for your drug requires expenditure of resources and time, along with specialised expertise. We will freely provide to you some of all of this!

From the medical part of all relevant certificates, like preclinic, clinic and medical statements, up to the final marketing authorisation.

  • Informationsbeauftragter § 74 a AMG 
  • Examination of compliance for markings, PIL, SmPC with the marketing authorisation contents and the registration.
  • Control and release of primary/secondary packaging material
  • Control and release of the SmPC
  • Compilation and treatment of expert certificates to the clinic and pharmacology toxicology part within the scope of marketing authorisation procedure and development projects.

  • Literature research
  • Support and maintenance (Inclusively per active substance / marketing authorisation 300.00 euros) for the conversion of the Pharmacovigilance directive 2010/84/EU as well as the EU regulation 1235/2010 from the 15th of December 2010, which contains that all product information about every European marketing authorisation (nationwide, MRP/DCP, centralised) has to be transmitted electronically to the EVMPD data bank of the EMA.

Pharmacovigilance Service

To enable you to apply your resources on tomorrow's business, we provide to you our Pharma-Resources for the maintenance of your already well-established products.

We know that products, which are already established on the market, also require long-term and specialised maintenance – and we will take care of this for you! We will perform the entire scope of pharmacovigilance measures for your drugs, assume the responsibility for drug safety and upon request we provide the Stufenplanbeauftragten – or the "Qualified Person for Pharmacovigilance".

  • Stufenplanbeauftragter § 63 a AMG & EU - QPPV
  • Compilation and reworking of a Pharmacovigilance – System
  • Use of Pharma Resources` Pharmacovigilance- System
  • Compiling and accommodation of all necessary SOP´s
  • Processing of adverse drug reactions
  • Supervision of the PSUR – appointments
  • Compiling of PSURs

Sale of Dossiers & Marketing Autorisation & API

Whoever has once again run short of the resource called "time" can access our portfolio of dossiers and marketing authorisations – on the fast track!

We offer our customers various dossiers and marketing authorisations and/or doublet marketing authorisations for different pharmaceutical forms. We advise the particularly hurried among our customers that some of these drugs are still under patent protection and may only be sold following the expiration of the patent protection!

  • Current dossiers
  • National marketing authorisations
  • European marketing authorisations
  • Internationalisation strategies
  • Trade with well-chosen APIs

 

On the next page you find a list of Dossiers, Marketing Authorisations and APIs.

Licensing out of Critical Care Products

If somebody wants not to hold and maintain a own marketing authorisation, and want to concentrate completely upon the distribution of a product. Pharma Resources can offer a joint distribution right for different marketing authorisations.

A licence on a national marketing authorisation can also be very interesting for export markets and puts a favorable possibility to open new markets.

On the right side you find our actual marketing authorisations:

  • 5-FU
  • Calciumfolinate
  • Docetaxel
  • Doxorubicine
  • Epirubicine
  • Gemcitabine
  • Irinotecan
  • Methotrexate
  • Ondansetron
  • Oxaliplatin conc.
  • Oxaliplatin lyo.
  • Paclitaxel
  • Topotecane
  • Ropivacaine
  • Vinorelbine
  • Zoledronic acid

 

 

Quality Management, Batch release & Audits

If you would like to take a look at the quality of your suppliers, then utilise the services provided by our specialised experts!

We know them all: Good Manufacturing Practice, API Audits, state-run monitoring or inspections by official agencies. Regardless of whether you would like to take a look at your suppliers' quality or your own quality – we ensure safety when it comes to quality!

To have your drug procured via our channels saves not merely resources and time, but also hard cash!

Since we simultaneously take care of the supply with marketing authorisations-compliant products during the organisational establishment of development projects with contract manufacturers for chemically- defined and biotechnological drugs for several customers at a time, we can pass the attained cost effect on to you.

  • API-Audits, Third Party GMP-Audits
  • Assistance in self-inspections
  • Cost-Sharing Audits
  • Searching for starting materials and Contract Manufacturer 
  • Product transfer – product establishment
  • Risk management
  • Manufacturing authorisation for the commercial release of drugs
  • Compiling and accommodation of a QS – System
  • Adaptation and review of Master-Batch-Records
  • Compiling and review of validation plans and reports
  • Organisation of stability studies
  • Compiling and review of PQR (Product Quality Reviews)
  • Use of the manufacturing and import license of Pharma Resources
  • EU batch release for the market by Qualified Person.

Contract Management and Consulting

We know to conclude contract relations in the pharmaceutical sector.

Simply use our Know How. 

We will take over the role of a moderator and give you support during the negotiation and organisation up to the signing of the contract. In this case contracts will come to an end very easy.

  • Contract review, risk management and actualisation
  • License- , Technical and Quality- , Supply Agreements- Consulting - Negotiation
  • Proof of adequate prices for staring materials and the finished product 
  • Support for changes of manufacturer and supplier
  • Consulting: Marketing Authorisation Strategies, Added Value, Supply Chain, Business – Development,
  • Compiling of business plans

Our Aims

As Pharma Resources, we primarily pursue a single aim: to be for our customers the partner, service provider or expert needed in order to be able to successfully transact business – once and then again!

We know: Success has many fathers – yet indeed, from nothing, nothing comes! This is why we perform our work for our customers with dedication and passion.

Regardless of whether we serve as a reliable partner who assists you with advice, as a sectoral expert who solves your specialised problems - or as a "pooling specialist“ who ensures you measurable purchasing advantages – when we take action for you, we put our hearts into our work. After all, our success depends on your success. Also, business success is what drives us day after day!

Our Values

We are Pharma Resources - and as a team, we rely on common values: courage, performance, trust, responsibility, respect, integrity and transparency – these are the basis for our company's success.

Day after day, these values determine our actions toward customers and business partners – as well as within our team.

_Courage opens doors to the future.

Whoever seeks to create something new must part ways with that which is familiar. Even when changes are sometimes unsettling, we venture to break new ground day after day. In co-operation with you, we apply our courage and our team's abandon in order to always be one step ahead of established processes.


_Performance enables our company's success.

Whoever is not just interested in one's own success but is also willing to assume responsibility for customers' success must reliably and constantly perform at the highest possible level. We only promise what we can deliver – and take action rather than talking too extensively about it. After all, we know: Your success depends not on our promises, but on our performance for you!

_Responsibility determines our actions as a company.

Assuming responsibility for people is the good reason for companies in the pharmaceutical industry to critically examine each step in their value creation chain with the highest quality and safety standard – regardless of whether this takes place in-house or externally. You can rely on our Service, because we only deliver what we could take responsibility for.

Our Values

_Respect establishes partnership-based co-operation.

Whether within our team or in contact with you – in the context of our business relationships, we strive for a spirit of co-operation which in the context of all of our specialised scientific expertise is based on respect for different insights, practises and experiences. This is the only way that we can learn from each other and benefit each other.


_Integrity ensures our credibility.

Only someone who takes action day by day in keeping with personal convictions, standards and moral concepts can be true to oneself and a reliable and at any time credible partner to a counterpart. That's why in our dealings with you, we do not float with the tide – rather, we are who we are – today, tomorrow and likewise the day after tomorrow.

_Transparency permits mutual trust.

To trust a person requires the ability to be certain of one's expectations of the other person. Also, requires the ability to be certain of this itself requires the understanding of that person's logic and manner of action. In order to be able to be understood, we at Pharma Resources rely on maximum transparency in everything we do – our preparatory effort to ensure a trusting relationship with you!

Our Network

We have access to Pharma Resources – on a worldwide level! To reinforce our own Pharma Resources, we have established partnerships in Europe, as well as in North, Central and South America and Asia. Our network likewise encompasses labs for development services and routine analytics, such as API and finished-products manufacturers.

  • DexaMedica / Ferron – Indonesia
  • Heumann - Germany
  • Thymoorgan - Germany
  • Pioneer / Sanvin - India
  • Hexal - Germany
  • Xellex - Sitzerland
  • Haupt Pharma - Germany

  • DEMO S.A. - Greece
  • Laboratorio Reig Jofré S.A. - Spain
  • Selectchemie AG - Switzerland
  • A&M STABTEST  - Germany
  • DRELUSO Pharmazeutika  - Germany
  • Holopack GmbH - Germany
  • Farmalider – Spain
  • PharmaZell - Germany

Our Public Affairs

In order to be able to advise you comprehensively and appropriately, we ensure that our Pharma Resources are always up-to-date in accordance with the latest "state of the art" – and this not at least by the close exchange of expertise between colleagues under various offerings from specialised professional organisations.

Pharma Resources is a member of:

_ Bundesverband der Arzneihersteller e.V. (BAH – German Federal Drug Manufacturers' Association, a registered association).
As a member of the BAH, we are connected to an interesting network which not only offers us contact to other member companies, but also – beyond that several possibilities to provide continuing education to our team of experts.


_Deutsche Gesellschaft für Regulatory Affairs
.
The membership in the Deutsche Gesellschaft für Regulatory Affairs enables us to always maintain our knowledge base on regulatory and medical affairs at the "state of the art" level. Not at least by the way of the constant training and continuing education of our young employees up to the level "Master of Regulatory Affairs“ in the adjacent Academy operated by the company.

_various marketing authorisation circles.
We are a member of two marketing authorisations circles which enable us the close and interesting exchange of experience with representatives from other pharmaceutical companies concerning official enquiries such as marketing authorisations, quality and documentation.


_Pharma Lizenz Club Germany
.
We appreciate the Pharma Lizenz Club Germany for its first-rate network in the area of Business Development which time and gain offers us assistance, along with a profitable exchange of experience.

Your Pharma Resources

We are there for you, when you need us – always!

We hope to establish long-standing business relationships marked by a high level of openness and based on interpersonal co-operation – and that in the context of these relationships, we would come to know and respect each other, and enjoy long-term success.

Detlef Lürig
Diplom Ingenieur / MBA BioMedTech
Managing Director

Heidi Lürig
Managing Director 
 

Juliana Lürig
Business Lawyer LL.B
Assistent Managing Director