(Clinical, Investigators Brochure, CMC)

Technical Writing

The extensive experience of Ashuren’s consultancy team can help you with your regulatory submissions. Our staff has the scientific and technical expertise needed to write accurate, concise high quality submissions across a wide variety of product types and therapeutic areas. Ashuren's technical writers have the background, experience and know-how to write the following key documents for your submission:

• Investigator’s Brochure
• Product labelling materials
• Phase I and Phase I/II protocols
• Nonclinical summary and nonclinical overview (Modules 2.4 and 2.6)
• Quality Overall Summary (pharmaceuticals and biologics) (Module 2.3 and Module 3)

Submissions

We have experience in preparing a wide variety of submissions, in both Canada and the United States. Our experience allows us to review your submission and alert you to potential problems before you file.Pharmaceuticals, Biotechnologicals, Biologics and Medical DevicesU.S Submissions:

• Briefing packages (pre-IND, end-of-phase I/II, pre-BLA/NDA);
• Investigational New Drug Application (IND);
• Biologic License Application (BLA)/New Drug Application (NDA).
• Abbreviated New Drug Application (ANDA).
• U.S. Agent/Correspondent

Canadian Submissions:

• Briefing packages (pre-CTA for phase I, II, III, pre-NDS);
• Clinical Trial Application (CTA);
• New Drug Submission (NDS);
• Supplemental New Drug Submission (SNDS);
• Abbreviated New Drug Submission (ANDS).

Medical DevicesU.S Submissions (CDRH):

• Device Classification Requests [513(g)]
• Premarket Notifications [510(k)]
• Premarket Approvals [PMA]
• Investigational Device Exemptions [IDE]
• Advice on labelling, instructions for use, technical documentation
• U.S. Agent/Correspondent

Canadian Submission (TPD):

• Medical Device Licence Applications [MDLA]
• Premarket Review Documents
• Investigational Testing Authorizations [ITA]

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