Document Formatting

To ensure standardized, compliant, and expertly designed Regulatory submissions for expedited approvals, Freyr's skilled document formatting services are tailored to meet the specific demands of each organization.

Document Formatting - Overview

In the complex landscape of Regulatory submissions, ensuring that documents are accurately formatted and compliant with agency standards can be a daunting challenge for pharmaceutical, biotechnology, and medical device companies. Inconsistent documentation can lead to delays, rejections, and increased costs.

At Freyr, we recognize that preparing and submitting Regulatory documents is a crucial phase in the product development lifecycle. Ensuring that these documents are accurately formatted and compliant with Regulatory agency standards is vital for successful submissions. Our document formatting services are designed to offer comprehensive support for all your Regulatory publishing needs, ensuring legible documentation and assistance with special characters, fonts, and styles.

Every company must have a standardized style sheet. This standardization ensures that documents generated by different team members are uniform in appearance, facilitating seamless integration when merging data from various sources. By adhering to a standardized style, discrepancies, and overlaps in data presentation are avoided, resulting in a cohesive and professional final document.

Customization and Flexibility

Our experts cater to different customizations that clients may request as standard practice. We understand that different companies have unique style requirements, and we pride ourselves on our flexibility to accommodate these needs. Our comprehensive overview of activities includes receiving documents, checking for compliance, and ensuring consistency and accuracy throughout the submission process. Our adaptable approach ensures that we can personalize our services to fit your company's distinct style preferences, ensuring a seamless and professional final document.

Comprehensive Word Formatting Activities

Our comprehensive list of activities includes but are not limited to:

Tailored Templates for Regulatory Compliance

Freyr offers a range of customizable templates, from Model 1 to Model 5, specifically designed to incorporate data across various sections such as clinical, non-clinical, and CMC (Chemistry, Manufacturing, and Controls). These templates ensure that your documents are not only compliant with Regulatory standards but also tailored to your company's specific requirements.

Commitment to Quality

At Freyr, we are committed to providing our clients with high-quality document formatting services that streamline the Regulatory submission process. Our attention to detail and adherence to Regulatory standards ensure that your documents are submission-ready, helping you achieve faster approval times and market entry.

Document Formatting

  1. We have a dedicated team for formatting various types of documents with precision
  2. We develop customized templates to ensure standardization and consistency in document creation
  3. Our style sheets ensure that document content meets client expectations
  4. We use a meticulous, process-driven approach to eliminate discrepancies in developed documents
  5. We offer ready-to-use templates for swift document development
  6. We have a proven track record with over 50,000 documents developed for various applications like IND, ANDA, and NDA
  7. Our templates are accepted across different markets including the US, EU, HC, and GCC
  8. We use ICH-recommended granular templates to ensure accurate data capture
  9. Our detailed templates provide clear guidance on information to be filled in each section, enhancing clarity and accuracy
Document Formatting
  1. Freyr provides tailor-made approaches to meet diverse client expectations, ensuring personalized service
  2. Our team has the ability to quickly adapt to last-minute changes, providing flexibility and responsiveness
  3. We have expertise in formatting complex tables, figures, and appendices to meet client and Health Authority (HA) requirements
  4. We can upscale or downscale resources based on the priority of activities, ensuring efficient resource management
  5. Our comprehensive in-house style guides are perfect for clients seeking to harmonize content across different functions
Document Formatting

Unlock the Power of Document Formatting

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Celebrating Customers Success

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​