GMP-analysis und GMP-consultation
Solid base for optimization of your QA-System is given by a thorough analysis of your GMP status and a consultation which offers you individual answers to eventually existing gaps.
We offer you guidance and support for planning improvements and implementation of measures.
GDP-analysis und GDP-consultation
End of 2013 the new Good Distribution Practice Guideline has led to a series of changes.
Are you already prepared?
We will be happy to provide consulting on this topic. We also perform GDP-Audits on your behalf.
APPLICATION FOR PERMITS (MIA, WDA, Narcotic Drugs)
PharmaSupport supports you in applying for manufacturing-, import-, wholesale- and narcotic drugs authorisations.
We develop the project plan, prepare the application documents for you, coordinate the work on the Q-system in consultation with the responsible authorities and, if necessary, provide the responsible persons. We also prepare the company for the acceptance inspections.
In this way, PharmaSupport has successfully helped various companies and pharmaceutical entrepreneurs to obtain their licenses in recent years.
Set up, adaption and updating of quality systems
Based on an analysis of requirements PharmaSupport takes over the design of your Quality-System.
For you we create the necessary system documents, like SMF, quality manual, SOPs etc.
Creation of QA-documents
Many documents are necessary to ensure compliance. We support you to create qualification and validation documents, PQRs (Product Quality Reviews), etc.
GMP in-house training / external guest speakers at seminars
Due to our expertise, we are able to offer you practical GMP-training. We offer general courses as well as in-depth training on special topics in the GMP-/GVP-/GDP- area.
Preparation of inspections
Take advantage of our comprehensive experience in the area of inspections to prepare you for the visit of your authority.
Depending on your demands we make an individual analysis of your Quality Assurance System, offer mock-audits and help you filling existing gaps. Your employees will be prepared by training to act properly during audits and inspections.
Worldwide Audits of suppliers
Take advantage of our long lasting experience in performing audits at pharmaceutical companies, raw material manufacturers and equipment constructors.
Tracing and tracking of Changes, CAPAs etc.
Sometimes the tracking of measures fails due to lacks of capacity. We support you and offer consistent follow up even of complex topics.
Creation of Quality Assurance agreements
The existence of a contract concerning every manufacturing process which is performed by third parties is obligatory. Profit from our knowhow concerning GMP-contracts. We help you to create Quality Agreements fulfilling the GMP requirements but also include all your individual demands.