Providing regulatory documents - request form

Part of our Transo-Pharm service in regulatory affairs is to send necessary documents, such as Drug Master Files, Letter of Access / Authorisation and Declaration of Accesses to CEPs to our customers for their regulatory activities.

​The scope is wide with many special wishes and requirements.

We`re experienced in submissions, variations, amendments and annual reports in established markets like Europe, USA, Japan and also in the non-regulated markets e.g. South America.

Communication is an integral part of walking the path to success together with our clients. To have communication with our customers at a high, accurate and precise level we developed some special tools.

For clarification for which API and reason our customer requested the documents we created the “request form”, it`s the best way to ensure that customers as well as authorities receive the documents they need. ​It`s based on a word-file, which consists of necessary fields to be clicked on and then filled.

The complete API name and manufacturer has to be provided on the top of the table. 
The table differentiates between US-TDP /Letter of authorisation, EU-Applicants Part / Letter of Access, CEP Declaration of Access, letter of Commitment and Letter of Authorisation for other countries.
For product specific details necessary data should be added in the table at the bottom of document or attached in a separate table (if more space is required because of several CEPs /LoAuths).

Don`t hesitate to contact us if you need more information.
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​Transo-Pharm SRA-Team

sop-ra-002_request_formular_documentation_2022-04-01web.pdf
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