Our Solutions

Technical Writing Expertise on Demand

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Script Molecular provides clients in the biotech and medical device industries with exceptional technical writing services for product development and regulatory submissions. Our writers work on controlled documents, work instructions, required forms, and many others. We provide technical writing consultancy work for FDA and other regulatory agency submissions and other technical document services.

Technical Writing Expertise on Demand

Script Molecular provides clients in the biotech and medical device industries with exceptional technical writing services for product development and regulatory submissions. Our writers work on controlled documents, work instructions, required forms, and many others. We provide technical writing consultancy work for FDA and other regulatory agency submissions and other technical document services.

Explore our services

Technical Writing Services Tailored to Your Business

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Our technical writing consultants are trained by the best industry experts and have worked on various products and projects. We can create customized documentation templates or recommend processes to address your needs. We also deliver recommendations on report and protocol components to include and can customize these elements to meet your needs.

Technical Writing Services Tailored to Your Business

Our technical writing consultants are trained by the best industry experts and have worked on various products and projects. We can create customized documentation templates or recommend processes to address your needs. We also deliver recommendations on report and protocol components to include and can customize these elements to meet your needs.

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Precision and Good Practices

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With almost two decades of experience in the highly regulated life science and biotech industry, we understand the precision required for technical writing. We value proper documentation, critical in medical device development and production. Our company strictly follows GDPs (Good Documentation Practice) necessary for GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) compliances as well as CLSI (Clinical and Laboratory Standards Institute) guidelines.

Precision and Good Practices

With almost two decades of experience in the highly regulated life science and biotech industry, we understand the precision required for technical writing. We value proper documentation, critical in medical device development and production. Our company strictly follows GDPs (Good Documentation Practice) necessary for GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) compliances as well as CLSI (Clinical and Laboratory Standards Institute) guidelines.

Ensuring Regulatory Compliance

Our team provides expertise on existing documentation to improve compliance. We excel at technical writing for life science companies to meet regulatory compliance. With our experience setting up companies to comply with ISO 13485 regulations, we'll ensure your protocols and final reports meet standards and exceed expectations.

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Our specializations

With almost two decades of experience in the highly regulated life science and biotech industry, we understand the precision required for technical writing. We value proper documentation, critical in medical device development and production. Our company strictly follows GDPs (Good Documentation Practice) necessary for GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) compliances as well as CLSI (Clinical and Laboratory Standards Institute) guidelines.

Comprehensive technical writing and documentation work for

  • FDA Pre-Submissions and Submissions
  • Submissions to other regulatory agencies
  • Bioproduction
  • Standard Operating Protocols (SOPs)
  • Training documentation creation
  • Protocols
  • Summary Reports
  • Transfer to manufacturing
  • Quality by Design
  • ISO 13485 regulations and certification support
  • Specifications
  • Investigations
  • Clinical Trial support documentation
  • Manuals
  • Quick User Guides
  • Product/Technical Bulletins
  • Scientific publications
  • Whitepapers

We handle the drafting, editing, and reviewing of technical documents, including

  • Product and Customer Requirements Documents
  • Product verification and validation documents
  • Risk Assessment
  • Data analysis
  • Device History Files
  • Device Master Records
  • Batch Records
  • Forms
  • Manufacturing processes and protocols
  • Methods
  • Logbooks
  • QC Methods
  • Summary Reports
  • Validation Master Plan Procedures
  • White Papers
  • Work Instructions (workflows, processes, clinical trials)
  • Templates
  • FMEA

We are highly familiar with the various processes and documentation needed when interacting with health and safety agencies such as the

Our Process

1
Pre-project consultations and coordination

First, we will determine the specific objectives of your project. Then, we will identify the appropriate format, documents and project requirements.

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2
Project management

Our consultants will work with your team of experts on staff to assist with processes, documentation, regulatory compliance and everything in between

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3
Post-project support

We will work with your team to ensure that all requirements initially outlined are met and will support your project immediately afterward.

Our Process

1
pre-project consultations and coordination

First, we will determine the specific objectives of your project. Then, we will identify the appropriate format, documents and project requirements.

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2
Project management

Our consultants will work with your team of experts on staff to assist with processes, documentation, regulatory compliance and everything in between

DownArrow

3
Post-project support

We will work with your team to ensure that all requirements initially outlined are met and will support your project immediately afterward.

Partner With Us Today

If you're looking for a technical writing firm that can handle regulatory paperwork and generate compliance documents, look no further. Contact our company to schedule an appointment with us.

Book a Meeting