Fully concentrate available resources in your business on your core competencies.
We are competent, respond quickly, are able to listen carefully and to fully perceive customers' needs. We develop solutions hand in hand with our customers. When it comes to supporting you in DRA, your relief is our primary goal. That is what we start already in the definition phase. "Outsourcing" should really relieve you in all sub-phases.
"Lean Management" is not only something that makes our mission. In everlasting endeavour to eliminate wastage, we have systematically analysed and optimized our processes all those years. At that, common interests of the customer and the contractor have always been focussed.
These CDs could include your eCTD authorization dossier!
Our products for efficiency and safety
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Authorization / Development of New Markets
Are your innovations marketable? A central question that requires an answer! Our support for clarification:
Sound knowledge of the regulatory bases
Detecting pitfalls
Identifying chances and possibilities of your product
Stabilization of the product pipeline
Careful data processing = fast completion of the authorization procedure
A (Swiss) authorization - a sure value!
Dossier Care
Our portfolio considers all care measures of an authorization. Select the appropriate modules corresponding to your wishes or choose DRA-Full support.
Expertises
Issues that you are dealing with:
Due Diligence
Time to Market
Costs
Answers that reassure you!
Technical Writing CMC / Medical
Preservation of resources throughout the life cycle - there is our focus already in the preparation of the data of chemistry, production and quality control. As much as necessary, as little as possible - that is the art of CMC Writing! For the medical writing, Dr. Schwantes, with her profound knowledge, her broad-based expertise and excellent networking with renowned distinguished experts of science faculties as partners, is available to us.
Innovations
TPDC-Server
DRA-serv
eCTD docuBridge
DRA-Tracking Database
CEP-Monitoring Database
DRA Strategic Agility
DRA-Information Server
PM-Tool
Document Exchange Server
Key-Facts
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