Wondering How To Meet Your Regulatory Affairs Requirements? Read This!

In the times when new regulations are formed every day and there are strict regulatory requirements, pharma companies often look for advisors to guide them in respect to legal and scientific requirements and to obtain support for marketing authorizations for various regions.

For this purpose, regulatory experts are required who can advise the right strategy that suits each phase of product development. Regulatory help is the biggest help!

Regulatory writing makes for a crucial element in medical writing. Regulatory writers work on crucial documents right from the beginning of product development, like:

• Describing and reporting clinical data
• Working on regulatory submission reports
• Generating post-approval reports mentioning the use of a certain treatment for the patients

Some of the documents that a regulatory writer works on are:

• Clinical study protocols
• Clinical study reports
• Investigator brochures
• Common technical documents (CTDs)
• Integrated safety summaries
• Clinical evaluation reports
• Patient information leaflets

A regulatory writer works on producing these regulatory documents and all the documents must have strict adherence to regulatory guidelines. They should be capable of delivering the required and desired information precisely, unbiasedly and clearly to the target audience.

Clinical Study Reports (CSR) are the outcome of a lot of hard work and in-depth research of the study teams. It is extremely important to draft well-organized and quality regulatory documents. A well-drafted CSR helps in generating high-quality submission documents whereas any CSR lacking in accuracy and clarity will result in a delay in getting regulatory approval and will cost time and money for the benefactor.

Well-experienced and trained regulatory writers are required to deal with all the necessary documents as they help in adding value in generating clinical study documents. During the process of clinical research, regulatory writers can serve as a walking encyclopedia at every step. Regulatory writers are well-versed with all the global regulatory guidelines such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH), etc. and work in accordance with the preferred or required styles of the study teams/benefactors.

Regulatory writers can understand the complex scientific and statistical information and can serve as a guide to the clinical teams, including experts from various fields such as pharmacovigilance, regulatory affairs, clinical statistics, etc. They present the information in an organized and simple manner for it to be understandable. They interpret the results and are in charge of presenting clear and unbiased conclusions.

Why go for outsourced regulatory services?

Regulatory affairs are very crucial, and many firms hire regulatory writers via outsourcing. When deciding whether to outsource your regulatory writing team, cost analysis plays a major role. It is essential to present complex information/data clearly post accurate interpretation within the strict and short timelines. In such a situation, outsourcing experienced regulatory writers can be a wise option as it will help to maintain the quality of documents and will also eliminate the risk of failed submissions within the timelines.

By tapping onto the resilience of the expert team of regulatory writers, who are well-aware of the recent guidelines, work efficiency is promoted for your organization as your deliverables will have timely submissions and it can also prove to be cost-effective. The ever-changing publication demands can sometimes increase the workload on your in-house team, and you might struggle to get the work done and hiring a full-time team of regulatory writers might not be the wisest option, cost-wise. By outsourcing skilled regulatory writers, you can cut the extra cost and get your work done efficiently.

Outsourcing writers exposes your organization to a greater docility and by maintaining long-term relationships with outsourcing firms, you can get your work done in future too.

Turacoz Healthcare Solutions equips with a dynamic and highly skilled team of regulatory writers who are always committed to deliver projects timely and with strict adherence to all the guidelines. The regulatory experts can provide you with strategic advice and take full responsibility of producing regulatory documents.

Turacoz extends its support to pharma and healthcare sector in various ways:

• Regulatory affairs & consultancy
• Regulatory writing
• Safety reporting

Turacoz has expertise in delivering pre and post-approval submission documents, QC (Quality check) & QA (Quality Assurance) projects. The dais that we work on is quite large, covering drugs, generics, biosimilars, biologics, diagnostics, biologics, medical services, immunology, etc. The ICH-GCP and country specific guidelines and templates are kept under strict consideration while working on the documents and it is ensured that the documents submitted are of high quality.

Turacoz Healthcare Solutions is a medical communication firm, dealing with services like medical writing, publication writing, pharmacovigilance support, regulatory affairs, real-world evidence, medico-marketing and clinical trial support. To know more about our services, you can get in touch with us at hello@turacoz.in