Overview

The success or failure of new compounds and devices depends on how effective (you communicate) is your communication with Regulatory Authorities while obtaining market authorizations for new products and/or retaining existing licenses. Not only the documentation of unorganized Clinical Trials data but also the reports on safety information of devices needs to be well-written as per the HA guidelines. Otherwise which, poorly structured documentation and unclear communication may result in non-compliance and may lead to multiple resubmissions affecting the overall cost.

In such scenarios, organizations look for an exclusive Regulatory partner who has specialized end-to-end medical writing expertise with comprehensive knowledge on clinical trial lifecycles to put across the scientific and clinical information in a clear, concise and compliant way.

Freyr’s Scientific and Medical writing team has proven expertise in delivering world-class Regulatory and Medical Writing services for its growing clientele of (global large) Pharma, leading CROs and other Biotech companies adhering to stringent timelines and high-quality parameters. Freyr is a preferred global Medical Writing services provider for both writing and document level publishing requirements. Freyr has extensive experience and capability of presenting the data as per the client requirements.

Freyr’s medical writing team consists of medically qualified (Medical and Paramedical), skilled and experienced professionals from pharma and clinical research industry. The team can author drafts, coordinate client reviews, perform the quality check, and manage the project management of medical writing activities.

 

Freyr Capabilities

Clinical Trial Documentation Writing Capabilities:

  • Clinical Study Protocols- including new protocols, amendments, and administrative letters
  • Investigator’s Brochure- de-novo and updates
  • Clinical Study Reports – shell writing, topline summary, synoptic, abbreviated and full submission reports
  • Safety Narratives - Brief and full narratives
  • Clinical Trial Disclosures in ClinicalTrials.gov/ EudraCT registries
  • Informed Consents 

CTD Modules Writing Capabilities:

  • Clinical Overviews (eCTD Module 2.5) including literature review and references
  • Clinical Summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety
  • Non-Clinical overviews (eCTD Module 2.4) including literature review and references
  • Non-Clinical written and tabulated summaries (eCTD Module 2.6)

Other Drug Development Documents:

  • Briefing documents
  • Clinical development plans
  • HA query responses
  • Topline summaries
  • Development safety update reports
  • IND annual reports 

Quality Control Capabilities:

  • Manual and electronic proofreading
  • Content review with various source documents
  • Medical review of the documents

Publishing & Document Editing:

  • Document editing
  • Document level publishing

Technology Services:

  • Document Repository: To store and archive the regulatory documents
  • Document Manager: To help in assigning parallel cross-functional review, tracking the status of various milestones (e.g. writing, review, approval etc.) for the documents during its lifecycle
 

Freyr Advantages

  • In-depth Regulatory knowledge perfectly integrated with IT capabilities
  • Complete understanding of the complex drug development process, including NCEs, generics, biologics and biosimilars
  • Experience in working across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
  • Defined processes of thorough scientific, medical, editorial and quality control review in‑house prior to sponsor review
  • Experience in writing documents for various phases of clinical development including Phase I to Phase IV, post-marketing surveillance studies (PMS) and post-authorization safety studies (PASS)
  • Well-versed in working with various stakeholders like clinical operations, data management, biostatistics, medical and safety teams to deliver documents
  • Timely delivery with the highest standard of quality 

Medical Writing CoE

Regulatory Competencies
X

Overview

  • Nonclinical overviews (Module 2.4)
  • Clinical overviews (Module 2.5)
  • Justifications for CDS
  • Updates to overviews
X

Summaries

  • Nonclinical and clinical summary
  • Integrated summary of safety
  • Integrated summary of efficacy
  • Summary of clinical pharmacology
  • Summary of clinical safety
  • Summary of clinical efficacy
X

Clinical Protocols

  • Protocols and protocol amendments
  • Protocols for first in human studies including SAD, MAD, ADME and drug interaction studies
  • Proof of concept, therapeutic, exploratory and confirmatory studies across diverse therapeutic areas
  • Bioequivalence studies
X

Clinical Study Reports

  • Shell preparation
  • Clinical phases I -IV
  • Post marketing studies
  • Post authorization safety studies
  • Bioequivalence studies
  • CSR narratives
  • Synoptic & abbreviated CSRs
X

Investigator's Brochure

  • New investigator’s brochure (IB)
  • Update of IBs with preclinical data
  • Update of IBs based on the clinical studies conducted
  • Life cycle management
X

Quality

  • Medical expert review
  • Data quality check
  • Editorial check
  • Content review
X

Clinical Trial.gov and EudraCT

  • Protocol disclosure
  • Protocol updates & amendments
  • Study results posting
  • Posting of updates & amendments to results
X

Publication Writing

  • Publication plan
  • Abstracts
  • Manuscripts
  • Slide decks
  • Posters
 

High Quality, Error Free Documents for Global Top 20, Pharma Company 

Freyr helps a global client with fast-track Preparation of Protocols, Protocol Amendments, IBs, and CSRs in stringent timelines providing significant cost benefits.

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CLIENT TESTIMONIALS

 
  • Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!

    Senior Regulatory Associate, Worldwide Regulatory Strategy
    A leading research-based global Biopharmaceutical Company

  • On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire Freyr team for partnering in our mission to serve patients.

    - Director, Supplier Performance Management, Global Regulatory Affairs & Safety
    Forbes Global Top 10 Biopharma Company

  • Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.

    We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.

    – Program Manager, Regulatory Affairs – Global $1Bn Pharma Company

  • Thanks for the great work you are doing, sharing the great principles that Freyr uses for its employees and your focus on sustainability.

    – Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company