Fully concentrate available resources in your business on your core competencies.

For nearly 20 years, we have dealt with all tasks related to the authorization of human and veterinary medicines. During this time, a variety of experience has been accumulated in contact with authorities and industry.

We are strong in the control of Drug Regulatory Affairs processes. We are competent, respond quickly, are able to listen carefully and to fully perceive customer’s 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
DRA-serv
eCTD

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!

Lifecycle Management

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, partners with profound knowledge, broad-based expertise and excellent networking with renowned distinguished experts of science faculties as partners are 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
  more>