Regulatory Affairs, Technical Writing | IND Modification for Phase I Clinical Trial

Regulatory Affairs, Technical Writing | IND Modification for Phase I Clinical Trial

IND Modification for Phase I Clinical Trial

IND Clinical Trial Technical Writing in preparation of FDA submission
  • Area: Greater Seattle Area
  • Project Type: Regulatory Affairs, Technical Writing

About this Project

OBJECTIVE

Client received FDA responses to initial Phase I Clinical Trial submission. Client required support in ensuring documents were modified and complete for FDA submission.

SERVICES

PSC® supported a small, start-up biopharmaceutical company with their Investigational New Drug (IND) application. With commentary from the FDA and a short time-line, PSC provided updates and modifications to the IND Phase I Clinical Trial Submission to ensure FDA approval. PSC® also provided Strategies for Optimization of Design of Forms to set the client up for success for future submissions.

PROJECT SUCCESS

PSC® has successfully completed the IND Modification for Phase I Clinical Trial within scope, schedule, and budget, and received outstanding feedback from the client’s Executive Team.

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Commissioning, Qualification, Validation and Engineering services for the clients manufacturing facility since its inception.

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Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Greater Los Angeles Cleaning Validation

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

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Extensive Technical Writing & Validation Execution 

Extensive Technical Writing & Validation Execution 

Extensive Technical Writing & Validation Execution

Multiple Technical Writing Assignments For Test Plans and Similar Projects

  • Area: Greater Baltimore
  • Project Type: Technical Writing

About this Project

OBJECTIVE

PSC® provided project schedule oversight through the entire project

SERVICES

PSC® performed technical writing support for 3 months utilizing a Senior Technical Writer. The project started on 6/10/2020 and concluded on 9/10/2020 or agreed upon timeframe. PSC® provided project schedule oversight through the entire project. An initial period of detailed planning occurred upon project commencement. Our Account Manager worked with the company designee to plan the execution approach for the whole project. The client then added a second project to create executable tables for key assay test plans from their narrative document. These test plans are created in such a way, so that they are easily adaptable to new assay test plans and or may be used to update existing test plans.

PROJECT SUCCESS

For an initial project, PSC® provided personnel with both extensive technical writing and validation execution experience to offer a well-rounded and inclusive view to write an operations manual and maintenance manual for proprietary critical equipment. In addition, with the second project, by utilizing a senior technical writer / senior validation engineer PSC® provided not only technical expertise but the crucial component of personnel with extensive experience in executing validation documents. This experience harmonizes the technical side with the practical knowledge of executing to create documents that effectively meet the client’s needs.

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PSC provided the client with Non-Medical Technical Writing Support Project.

Compliance for Computerized Systems

Required support for compliance and validation activities related to the Software Transition Project.

Engineering Projects & New Equipment Implementation

Required technical writing support for engineering projects and new equipment implementation.

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Technical Writing | Conducting Investigations & Resolving Nonconformance’s

Technical Writing | Conducting Investigations & Resolving Nonconformance’s

Technical Writing | Conducting Investigations & Resolving Nonconformance’s

Generated SOP’s for Equipment Facilities and Utilities.
  • Area: Greater Los Angeles
  • Project Type: Technical Writing

About this Project

OBJECTIVE

Technical Writing Services.

SERVICES

Provided technical writing services. The scope of technical writing to be provided included: Lot release- was actually researching errors and inconsistencies in existing records.  Also generated SOP’s for equipment facilities and utilities.

EQUIPMENT USED

  • Office space
  • Desks
  • Internet connection
  • Copy machine

PROJECT SUCCESS

PSC® provided two experienced technical writing consultants for this project. The project successfully took around 1020 hours.

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Extensive Technical Writing & Validation Execution

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Technical Writing | Researching Errors & Inconsistencies In Existing Records

Technical Writing | Researching Errors & Inconsistencies In Existing Records

Technical Writing | Researching Errors & Inconsistencies In Existing Records

Required Technical Writing for cGMP Documents, SOP’s, and Others
  • Area: Great Los Angeles Area
  • Project Type: Technical Writing

About this Project

OBJECTIVE

Client required assistance with technical writing on their projects.

SERVICES

PSC‘s® technical writer for this project primarily wrote, edited, and reviewed cGMP documents, Systems Specifications, SOPs, and related materials while maintaining standardized documentation practices for recording details of new processes. The technical writer maintained standardized language and documentation practices that allowed  execution of documents. The technical writer established and supported documentation practices that reduced review times and deviation by researching errors and inconsistencies in existing records and communicating effectively with appropriate personnel. The technical writer also worked with internal teams to understand system documentation requirements, analyzed current content to make improvements as necessary, and maintained documentation pertaining to systems operation and user documentation.

EQUIPMENT USED

  • “FPC50W – Isolator (Watson Marlow-Ziel)
  • FlexPro 50 – Isolator (Groninger – Ziel)
  • Steris Autoclave (27 cu ft. production)
  • Santimatic COP washer
  • Seidnator (2)
  • Innova Deneste
  • USP water, Pure steam, Compressed air, Nitrogen, AHUs, Water for Injections. -Not tools used

PROJECT SUCCESS

PSC® successfully assisted in technical writing for quality and cost-effective projects over the course of 7 months.

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Generated Standard Operating Procedure’s for Equipment Facilities and Utilities.

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Technical Writing | Engineering Projects & New Equipment Implementation

Technical Writing | Engineering Projects & New Equipment Implementation

Technical Writing |
Engineering Projects & New Equipment Implementation

Technical Writing Support
  • Area: Waco, TX
  • Project Type: Technical Writing

About this Project

OBJECTIVE

The Facilities Department in Waco, Texas required technical writing support for engineering projects and new equipment implementation.

SERVICES

PSC provided the Texas facility with technical writing support for engineering projects and new equipment implementation. Documents included Functional Risk Assessment, System Risk Assessment, Standard Operating Procedures, Work Instructions, Traceability Matrix, User Requirement Specifications, and Functional Requirement Specifications.

EQUIPMENT USED

  • “FPC50W – Isolator (Watson Marlow-Ziel)
  • FlexPro 50 – Isolator (Groninger – Ziel)
  • Steris Autoclave (27 cu ft. production)
  • Santimatic COP washer
  • Seidnator (2)
  • Innova Deneste
  • USP water, Pure steam, Compressed air, Nitrogen, AHUs, Water for Injections. -Not tools used

PROJECT SUCCESS

PSC performed the technical writing tasks per client policies and the industry standard in a timely manner within the timeline.

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