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Preparation (Medical Writing)

 

The staff with abundant documentation experience in each field takes charge of the documentation service of RPM. Moreover, a high quality documents are prepared with the thorough and accurate checking by staff before the delivery.

Not only in the field of pharmaceutical products, but also we handle the wide range of field such as quasi-drug, medical device, pesticide, veterinary drug, cosmetics, and functional foods.

Since our staffs have abundant experiences in CMC, non-clinical studies and clinical trials, we can prepare any sorts of documents.

   Document Preparation service
 
 
 ■ Handling field
   Document Preparation service
 
 
Pharmaceutical products,  quasi-drugs, veterinary medicines, agrichemicals, medical devices, cosmetics, and functional foods.

 

  
 
 ■ Support contents
  
 

 

■ Preparation of Investigator's brochure　
　 (CMC, non-clinical section, a clinical studies)

■ Preparation of application documents for
　 Common Technical Document
   (CMC, Non-clinical studies and Clinical sections)
■ Writing research papers

  
 

 Do you have any problems with following aspects?

・Shortage of the specialists who could prepare application documents for the joint development products
　and introduction of new products.

・Since you cannot supplement the human resource, you would like to use the outside agencies.
・Since the application timing was advanced, we would like to request the part or all of preparation of

　 application documents to outside agencies.

・ Increased the burdens on the section(person) in charge and feel a limit on the company’s stamina.

 

 Experienced staff of RPM will support the correspondence to competent authorities, and the documents preparation!

 

 Since our staffs have abundant experiences in CMC, non-clinical studies and clinical studies, we can support you in any sorts of documents preparation.

 

 The staff with abundant documentation experience in each field takes charge of the documentation service of RPM. Moreover, high quality documents are prepared with the thorough and accurate checking by staff before the delivery.