Building new business segments and cooperations
You are entrepreneur. So are we. With business ideas, practical experience, and our network, we support your expansion and reorientation
- in obtaining an official permission for manufacture, importation or wholesale
- in developing new pharmaceutical products
- in extending or shortening your value chain
- in building up new lucrative partnerships, locally or globally
As a specialized consultancy we can search for suppliers, service providers, contract manufacturers and strategic cooperation partners etc. on your demand, without divulging your identity. After determining your requirements and frame conditions in-depth, like time frame, budget, confidentiality requirements, etc. we obtain offers, references and other information for you, as well as clarifying regulatory and technical possibilities.
When organizing a possible cooperation, we carry out preliminary clarifications with authorities regarding the acceptance of partners and/or novel business models if necessary.
Quality assurance audits and due diligence audits with opinions signed by an EU-QP and therefore recognised under the EU-GMP Guide (Annex 16) are a focus of our activities.
We work together with specialist lawyers in order to draft contracts with your partners and to get other legal advice, if needed.
For your day-to-day operation, we can provide you with your own address permanently in the EU. Depending on the legal requirements, your own enclosed office space may be required, or your own mailbox with our postal processing service may be sufficient.
We are happy to advise you!
Import to the European Union
Our location on the EU’s external border as well as a long experience in the Swiss pharmaceutical industry make us first-choice partner for companies exporting to the EU.
An import of your finished medicinal products or active pharmaceutical ingredients can be organized at short notice. We hold an EU Manufacturing License (§13 AMG) and an EU Import License (§72 AMG).
Alternatively, we can establish a branch office in the EU for you with your own import license. In the initial phase or on a continuing basis we can perform the functions subject to pharmaceutical law, including Qualified Person for batch release and Qualified Person for Pharmacovigilance.
Training services
We gladly contribute our experience to training courses or conferences.
Examples
- In-company training “Training on GMP", Contract manufacturer drug delivery devices in Germany
- In-company training “Analytical method validation: Guidelines, principles, acceptance criteria, documentation, deviations, observations of inspections, new trends”, Developer and manufacturer of transdermal therapeutical systems in Germany
- In-company training “Handling of OOS results”, Manufacturer of active ingredients in Switzerland
- In-company training: Training for hosting risk-based inspections with focus on API for export to Europe, Manufacturer of active ingredients in China
- In-company training “Sampling of pharmaceutical ingredients and packaging material”, Manufacturer of active ingredients in Switzerland
- In-company training “Pharmaceuticals and medical devices – similarities and differences; manufacturing authorization and regulatory surveillance”, Manufacturer of Medical Devices in Switzerland
- In-company training “Import of active pharmaceutical ingredients and intermediates to the EU using the example of Germany”, Distributor of pharmaceutical active ingredients and excipients in Switzerland
- In-company training “Quality Risk Management, ICH Q9, EU GMP-Guide Part II, PIC/S GMP Guide Annex 20”, Pharmaceutical research and development company in Germany
- In-company training “Risikogerechte Qualifizierung” (Risk-based qualification), Manufacturer of active ingredients in Switzerland
- In-company training “Prozessvalidierung” (Process validation), Manufacturer of active ingredients in Switzerland
- In-company training “GMP in der Qualitätskontrolle” (GMP in quality control), Manufacturer of active ingredients in Switzerland
- In-company training “GMP in der Wirkstoffproduktion” (GMP in production of active ingredients), Manufacturer of active ingredients in Switzerland
- In-company training “Risikogerechtes Abweichungsmanagement in der Produktion” (Risk-based deviation management in production), Manufacturer of active ingredients in Switzerland
- In-company training “Warum GMP? Hintergrund und Motivation” (Why GMP? Background and motivation), Manufacturer of active ingredients in Switzerland
- In-company training “Qualifizierung und Validierung, Schwerpunkt Qualitätskontrolle” (Qualification and validation with focus on quality control), Manufacturer of active ingredients in Switzerland
- In-company training “Prozessvalidierung und PQ” (Process validation and performance qualification), Manufacturer of active ingredients in Switzerland
- In-company training “Abweichungsmanagement in der Produktion” (Deviation management in production), Manufacturer of active ingredients in Switzerland
- In-company training “Risikogerechte Qualifizierung, Wartung und technische Dokumentation” (Risk-based qualification, maintenance, and technical documentation), Manufacturer of active ingredients in Switzerland
- In-company training “Arzneimittelentwicklung” (Drug development), Manufacturer of active ingredients in Switzerland
- In-company training “Audits und Inspektionen erfolgreich begleiten” (Hosting audits and inspections), Manufacturer of active ingredients in Switzerland
- In-company training “Compliance with 21 CFR Part 11 and GAMP 5”, Manufacturer of active ingredients in Switzerland
- Presentation “Quality Risk Management, ICH Q9, EU GMP-Guide Part II, PIC/S GMP Guide Annex 20”, “Pharmaceuticals – from Research to Market, Quality and GMP “, Uni Basel
- Presentations and workshops „Clear Air, clean Water, clean Surfaces“, „Outsourcing of GMP activities – Finding the most suitable CMO for your needs“, „Audits, inspections and investigations“, „Quality Assurance Agreements“, „GMP and motivation for GMP“, „Organigram of a GMP manufacturing site“, „Maintenance and Repair“, „Preventive Maintenance“, „Zone Concept and Cleanroom Design: EU GMP Guide Annex 1“, „Outsourcing: Quality Assurance Agreements“, „Quality Risk Management ICHQ9“, Master’s degree course Medicinal and Industrial Pharmaceutical Sciences, ETH Zurich
- Presentation “Beschaffung und regelkonformer Umgang mit Arzneiwirkstoffen” (Procurement and GMP compliant handling of Active Pharmaceutical Ingredients), Seminar “Arzneimittel-Medizinprodukt-Kombinationen” (Drug – Medical device – Combinations), BioTOP Berlin-Brandenburg
- Presentation “Beschaffung qualitätsdefinierter Roh-, Hilfs- und Wirkstoffe auf dem internationalen Markt” (Acquisition of quality defined raw materials, excipients, and active ingredients on the international market), workshop “Umsetzung von ICH Q8, Q9 und Q10 in der Arzneimittel- und Wirkstoffentwicklung” (Implementation of ICH Q8, Q9 and Q 10 in drug- and active ingredient development), BioTOP Berlin-Brandenburg, Potsdam
Qualified Person / QP / FvP
We offer two options for batch release/certification of pharmaceuticals and active ingredients. A prerequisite for both options is that your quality management system and your products meet all essential requirements.
Option 1: If you have your own Manufacturing or Import Authorization (MIA): Our consultants can act for you as Qualified Persons in Germany and as Responsible Persons (FvP) in Switzerland. Our consultant will then be integrated into your organization with a job description and registered as external QP or FvP with your competent authority. This is interesting for manufacturing and importing companies that only have a small workload for a QP or FvP and/or need a registered, fully trained deputy in the event of peak or staff shortages. The external QP / FvP certifies your batches on behalf of your company; your company is the manufacturer or importer of these batches, even if our staff performed the batch release.
Before batch release, the QP / FvP must familiarise himself or herself with your company-specific quality systems before approval and will also be on site frequently afterwards. Therefore, we can only take over the external QP / FvP role for companies in our vicinity (Southern Germany and German-speaking Switzerland).
Option 2: If you do not have your own manufacturing or import permit: Alternatively, we organize the release or import of your products into the EU based on our own manufacturing and import permit. We offer this service to companies all over the world.
Assistance with inspections by authorities
We support you before, during, and after your next GMP inspection by the health authorities:
- evaluation of the need for action in a preliminary audit
- design and implementation of an efficient preparation plan
- training of your personnel
- hosting of the inspection by the authorities
- subsequent preparation and implementation of an efficient action plan
Internal and external audits
We carry out quality assurance audits (GMP, GDP, if necessary with additional consideration of ISO 9001 and ISO 13485) and due diligence audits. We also support you in the creation of an efficient supplier qualification program. After a risk analysis, we use on-site audits, audits by questionnaire or the systematic evaluation of other information.
Compatibility and stability studies
In co-operation with our qualified GMP-contract laboratorier we can offer complete studies: concept, plan, practical work, interpretation and report. In close collaboration with you we develop a concept that meets your requirements concerning timelines, budget and risk minimization.
After your approval, we create a plan based on this concept. With your assent it will be executed by our GMP-contract laboratories. We stay in contact with the laboratory the whole time. We are in charge of your study and audit the procedure. We keep you informed – according to your wishes at fixed dates and/ or at certain milestones. We write the reports in the format you require. If desired, we can provide you with a report that can directly be copied into your CMC-dossiers.
Creation of documents
We create for you
- site master files
- master plans and policies
- risk analysis
- qualification and validation documents
- SOPs
- manufacturing and testing regulations
- stability plans and reports
- forms and checklists
- job descriptions
- product quality reviews
- dossiers for certain medical devices
- etc.
We are also happy to take over the training. For validations and qualifications, we provide the concept, risk analysis, plan and report if desired – and carry out practical work at your site or in our contract laboratories.
Your Pharma office in the EU
We support pharmaceutical companies to establish a location in the European Union:
- advice
- networking support
- rental of offices in Loerrach
- "virtual office" with its own company sign in the entrance area, letterbox, central reception, postal processing and telephone service
- GDP storage or service "physical import site"
- assistance in applying for drug permits (manufacturing permit, wholesale permit, import permit, etc.)
- assistance in applying for drug approvals
- Qualified Person(s) and other batch release and certification professionals
Labelling of small batches for clinical trials
- Labelling of small batches of test medicinal products
- Printing simple labels or labelling with delivered labels, booklets, etc.
- Initial labelling and re-labelling
Primary Packaging in Clean-Room Environment
PharmaKorell is now offering primary packaging and sampling of solid dosage forms and APIs under clean-room conditions. Air quality is according to EU GMP Guide Annex 1 Class A (particles) and Class D (microbiology). The qualified pharma work bench is operated in a hygiene zone in our new building.
Please find our amended Manufacturing License and GMP Certificate in the CERTIFICATES section.
Storage
GMP/GDP compliant storage of small quantities at
- +15…+25°C
- +2…+8°C
- -30…-15°C
- below -60°C
GMP/GDP compliant storage of goods on Euro pallets at
- +15…+25°C
- +2…+8°C
- two pallet space heights: max. 115 cm and max. 230 cm
Import and release of IMPs to Great Britain
Together with our British cooperation partner we are able to release and certify IMP batches for clinical trials in Great Britain.
The process steps are:
- QP certification of your IMP batches on our EU MIA
- Execution of the QP Oversight Process on an MHRA MIA(IMP)
- Import of the IMP batches to Great Britain
How are the services remunerated?
Learn more about the remuneration of the services.
