Regulatory Writing

Streamline your regulatory approval process with our expert writing services

Our Services

Our Services:

Protocol Development and Writing

Our regulatory writing team has extensive experience in developing high-quality clinical study reports (CSRs) that meet the requirements of global regulatory authorities. Our CSRs provide a comprehensive and detailed account of clinical trial conduct, methodology, and results, ensuring that the data is presented in a clear and accurate manner. We adhere to ICH-GCP guidelines and other relevant regulations to ensure that our CSRs are compliant and of the highest quality.

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Investigator Brochures

We also specialise in the development of investigator brochures (IBs) that provide essential information about the investigational product to clinical trial investigators and site personnel. Our IBs are designed to be clear, concise, and informative, providing a comprehensive overview of the product's nonclinical and clinical data. We ensure that our IBs are regularly updated to reflect new data and emerging safety information.

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Protocol Development and Writing

Our regulatory writing team can assist in the development and writing of clinical trial protocols that are clear, concise, and scientifically sound. We work closely with our clients to develop protocols that meet the specific needs of their study, taking into account the study objectives, endpoints, and statistical considerations. Our protocols are designed to meet the requirements of regulatory authorities and ethics committees, ensuring that they are compliant and of the highest quality.

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Clinical Evaluation Reports

We have expertise in developing clinical evaluation reports (CERs) that meet the requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Our CERs provide a comprehensive evaluation of the clinical data for a medical device, ensuring that the device is safe and effective for its intended use. We adhere to the principles of clinical evaluation as outlined in MEDDEV 2.7/1 rev 4 and other relevant guidelines.

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Patient Information Leaflets

Our regulatory writing team can also develop patient information leaflets (PILs) that provide clear and concise information to patients about their medication. Our PILs are designed to be easily understood by patients, ensuring that they have the information they need to use their medication safely and effectively. We adhere to the requirements of the European Medicines Agency (EMA) and other relevant regulatory authorities to ensure that our PILs are compliant and of the highest quality.

Why US

CSRs and Protocols

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IBs

Therapy Areas

Years of Cumulative Experience

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Expert medical writers

Our team consists of experienced medical writers who have a deep understanding of various therapeutic areas and publication formats. They are skilled in crafting high-quality, engaging, and accurate medical content that meets the needs of our clients.

Tailored solutions

We understand that each client has unique needs and requirements. That's why we offer customised solutions to meet each project's specific goals and objectives.

Extensive background

Our team has an extensive background in various therapeutic areas, including oncology, neurology, cardiology, and more. We also have experience with a wide range of publication formats, including manuscripts, abstracts, posters, and clinical case reports.

Global-scale reach

We have a global network of editors and publishers, allowing us to provide our clients with unparalleled reach and visibility. Our relationships with these key stakeholders ensure that the right people see your medical content in the right places.

Streamlined review process

We understand that time is of the essence in the medical field. That's why we have developed a streamlined review process that ensures your medical content is reviewed and edited quickly and efficiently without compromising quality.

Rigorous quality control

We are committed to delivering the highest quality medical content to our clients. That's why we have implemented rigorous quality control measures, including multiple rounds of editing and proofreading, to ensure that your content is error-free and meets the highest standards of quality.

Blogs

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FAQ

What types of regulatory documents do you specialize in?

We specialize in a wide range of regulatory documents, including clinical study reports, investigator brochures, protocols, and more.

Can you help with the development of a regulatory strategy?

Yes, our team can work with you to develop a comprehensive regulatory strategy that aligns with your development goals and timelines.

Do you offer support for regulatory submissions and communications?

Yes, we can provide support for regulatory submissions and communications, including preparation of responses to regulatory agency questions and requests.