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We also have a strong quality review department that provides data integrity and editorial reviews for documents produced internally or those from customers’ own writing teams.Regulatory Writing for Individual Studies: In addition, we have expertise across 19 therapeutic areas.
These services can be offered on a stand-alone basis or as an integrated part of a clinical trial, drug development program or medical information service. All PPD documents undergo a rigorous review process to ensure that documents produced are of the highest quality.
A team of project-specific reviewers is selected to ensure the materials are grammatically correct, scientifically logical and completely accurate.
The Freyr medical writing team has proven proficiency in developing and delivering world-class Regulatory medical and scientific 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 also ensures that the writing is in line with the corresponding clinical research.
Medpace’s integrated team helps plan and coordinate each aspect of regulatory strategy and engagement, balancing strategy, data, analysis, and timelines by globally optimizing regulatory interactions and strategic approaches.
Please be aware that if you continue browsing the website without changing your cookie settings, you consent to this. and master’s level writers with diverse therapeutic backgrounds who can support preparation of a wide range of medical communication materials, including: Our medical writers prepare clear, well-written documents designed to exceed expectations in terms of both content and formatting.They possess strong project management and negotiation skills and support projects with multiple customer contributors and external thought leaders.They drive timelines, organize and lead authoring meetings, and reconcile sponsor feedback across functions to create consistent, scientifically cohesive documents and minimize nonessential customer oversight.Medical Writing is a vital segment of clinical research.It plays a critical role in the development and submission of clinical research documents and defines the success or failure of new medicinal products/devices.As Regulatory authorities expect precise and timely submissions of documents/dossier, any delay in this stage leads directly to a delay in realizing profits both in terms of achieving patient benefit and ROI.With a qualified (Medical and Paramedical) team of skilled and experienced medical writing professionals from pharmaceutical and clinical research industries, Freyr develops quality documents, performs peer review and coordinates client reviews, performs quality checks, and accomplishes the project management of various Regulatory, clinical writing activities in both Electronic Common Technical Document (e CTD) and CTD modules.Thought Leadership Many of our medical writing associates and members of our leadership team are active speakers and participants in forums within the medical writing community, including national and chapter conferences of the Drug Information Association, Drug Information Association Medical Affairs and Scientific Communication, American Medical Affairs and Scientific Communication, and American Medical Writers Association, as well as internal customer summits.Recent topics presented by our writers have included: In addition to providing support on an individual clinical trial or project basis, we have extensive experience in building functional service provider relationships (FSPs), offering collaborative and strategic solutions that provide layers of additional benefit to our customers.Freyr is a preferred global Regulatory writing services provider for writing, performing independent quality review, conducting thorough technical review of dossiers and identifying gaps/performing gap analysis in already prepared/compiled dossier.Our Regulatory medical writing professionals can cater to the needs of various regional Health Authorities (HAs) of North America, EU, Middle East and North Atlantic region, and other APAC nations including India, China, and Philippines.