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. Check out our presentation directly online, or download the presentation as a PDF. Download!
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 _1998 to 2002 – As a service provider for to a service provider for drug marketing marketing authorisations in Switzerland authorisation Pharma Resources was founded in 1991 by the With the strategic idea to assure the existing trade merchant Peter Franck in Ahrensburg, near business with our own dossier and marketing Hamburg. At the time of its foundation, the sole authorisations business, the Swiss-based company business activity performed by Pharma Resources Dolder AG had acquired Pharma Resources in was the trade in pharmaceutical raw materials. In 1998. However, in the following years, the the following years the company established strategy proved to be a disappointment: because services for marketing authorisations as additional Switzerland was not a member of the EU, the line of business under the Management of Dr. Dolder AG was not able to organise marketing Gabriele Schluttig as a supplement to dealing with authorisations for the European market from raw materials. The business developed there; at the same time, export certificates successfully; nevertheless, in 1998, Peter Franck prepared in Switzerland were not recognised. Due decided for personal reasons to sell his company to to that, there was no future for Pharma Resources the Swiss-based Dolder AG. in Switzerland.
Our History _2002 to 2010 – In the hands of two experts _2010 to the present back in Germany After Switzerland proved to be a disadvantageous As a well-established service company with location for the service business with marketing product-based unique selling points on the authorisations, Pharma Resources was taken over European health-care market, the company in a management buy out (already four years after Pharma Resources changed hands on 1 January the takeover by the Dolder AG) by the two 2011, passing to the ownership of the executives Dr. Gabriele Schluttig and Hermann entrepreneur family Lürig. Therefore, the 20-year Kopf. The company's main office was relocated success story of Pharma Resources merged with once again to Germany, this time to Dreieich near 25 years of personal market experience brought to Frankfurt am Main. As of 2002, with several bear by the new partner, Detlef Lürig. Associated interesting development projects, Pharma with the change in ownership, the company's main Resources succeeded in gaining renowned office was relocated once again: in 2011, the customers for the service business and laying a company moved from Dreieich near Frankfurt am broad cornerstone for the company's success in Main to Hameln an der Weser. the years that followed.
Our Services and Core competencies Resources for your success non-bureaucratic, authentic and professional. Regulatory Affairs Service Clinical & Medical Affairs Service Pharmacovigilance Sale of Dossiers, Marketing Autorisations & API Licensing out of Critical Care Products Quality Management, Batch release, Audits Contract Management and Consulting
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 Maintenance ,support and optimisation of your Regulatory & Due - Diligence Consulting marketing authorisations Execution of national, MR-, DC- and centralised National variations and EU variation procedures procedures Updates of marketing authorisation documentation Support by the treatment of marketing Re-formatting from NTA to CTD authorisation applications Readability tests Answering of deficiency letters
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 Literature research Examination of compliance for markings, PIL, Support and maintenance (Inclusively per active SmPC with the marketing authorisation contents substance / marketing authorisation 300.00 euros) and the registration. for the conversion of the Pharmacovigilance Control and release of primary/secondary directive 2010/84/EU as well as the EU regulation packaging material 1235/2010 from the 15th of December 2010, Control and release of the SmPC which contains that all product information about Compilation and treatment of expert certificates to every European marketing authorisation the clinic and pharmacology toxicology part within (nationwide, MRP/DCP, centralised) has to be the scope of marketing authorisation procedure transmitted electronically to the EVMPD data bank and development projects. 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 Stufenplanbeauftragter § 63 a AMG & EU - QPPV established on the market, also require long-term Compilation and reworking of a Pharmacovigilance and specialised maintenance – and we will take – System care of this for you! We will perform the entire Use of Pharma Resources` Pharmacovigilance- scope of pharmacovigilance measures for your System drugs, assume the responsibility for drug safety Compiling and accommodation of all necessary and upon request we provide the Stufenplanbeauftragten – or the "Qualified Person SOP´s for Pharmacovigilance". 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 Current dossiers marketing authorisations and/or doublet marketing National marketing authorisations authorisations for different pharmaceutical forms. European marketing authorisations We advise the particularly hurried among our Internationalisation strategies customers that some of these drugs are still under Trade with well-chosen APIs patent protection and may only be sold following the expiration of the patent protection! 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 5-FU also be very interesting for export markets and Calciumfolinate puts a favorable possibility to open new markets. Docetaxel On the right side you find our actual marketing Doxorubicine authorisations: 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 API-Audits, Third Party GMP-Audits not merely resources and time, but also hard cash! Assistance in self-inspections Since we simultaneously take care of the supply Cost-Sharing Audits with marketing authorisations-compliant products Searching for starting materials and during the organisational establishment of Contract Manufacturer development projects with contract manufacturers Product transfer – product establishment for chemically- defined and biotechnological drugs for several customers at a time, we can pass the Risk management attained cost effect on to you. 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.
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