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About:

The pharma industry is all about providing evidence of what you do. Procedures; protocols and reports. With my experience in the pharma industry coupled with my academic qualification and my years of experience as a top-rated freelancer, I will be able to provide you with documents as follows:

- CTD Dossier for product new product registration and renewal

- IQ; OQ; DQ and all instrument/equipment qualification documents

- SOP for raw materials and finished goods analysis

- Quality Manual

- Validation protocols and reports (including cleaning validation; product to product change over, etc)

- Validation Master Plan (VMP)

- Water Analysis

- Analytical method validation protocol and report

- Anual product review

- CAPA report

- Process validation protocol and report



The list is not limited to the above so feel free to get in touch anytime. 

N.B: For CTD dossier preparation, kindly get in touch with me first so we can make arrangements for all the required documents including the open part of the DMF (Drug Master File), the number of modules applicable ( only module 1 to 3 for some regions/Generic drugs)).

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