Any scientific report/document should be composed in a clear, concise, and compliant way and be validated by stringent quality control in Pharmacovigilance. It should convey scientific information without any ambiguity or misrepresentation.
Medical literature is an important source of information for suspected adverse reaction case reports. With stringent regulations, Marketing Authorization Holders (MAHs) may face the challenge of incorporating safety data into their Pharmacovigilance (PV) practices to achieve compliance.
The pharmacovigilance signal detection management process is a set of activities performed to determine whether there are new risks associated with a medicinal product or whether known risks have changed based on the examination of Individual Case Safety Reports (ICSRs), aggregated data from active surveillance systems or studies, and scientific literature information or other data sources.
Individual Case Safety Report (ICSR) standard varies with every product type. With the continuous increase in ADR cases from various sources resulting from research and development, there is always a need to align with improved ICSR case processing standards and regulations. In such scenarios, to comply with the Health Authority (HA) requirements, organizations might opt for specialized ICSR Pharmacovigilance services in accordance with the adverse event reporting system.
To protect the safety and efficacy of a drug, the Marketing Authorization Holder (MAH) must conduct pharmacovigilance aggregate reporting and safety writing and periodically submit the aggregate safety reports, also known as periodic reports or periodic safety reports, to the Health Authorities (HAs).
Non-clinical medical writing strategy plays a crucial role in drug development. A well-planned pre-clinical drug development strategy not only saves time and money in the lead compound development but also helps to identify failed compounds at the early developmental stages. A Regulatory expert providing seasoned expertise concerning Non-clinical Regulatory writing services can make such a revolution.
Clinical trial audits and clinical trial monitoring guarantee that the trial data is accurate, complete, verifiable, and in agreement with ethical and scientific norms. Clinical trial monitoring quality is the basis for efficient execution, and the success of each clinical trial depends on it. Robust clinical trial monitoring is vital to protect the integrity of the scientific data and yield valid Regulatory data.
Submission of documents post clinical research for Health Authority (HA) review requires specialized skill in clinical study report writing. Clear and precise clinical study report (CSR) writing helps reviewers comprehend the technicalities of clinical research, as a single error in clinical documentation may prove risky and costly for organizations, causing approval delays.
Regulatory medical writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Developing accurate clinical and nonclinical documents for Regulatory submission dossiers under medical writing requires an in-depth understanding, experience, and thorough knowledge of the Regulatory guidelines.
Medical Writing industry is on an upward surge, mainly driven by an increasing demand in Emerging markets to have high-quality documents authored to support timely drug approvals. At the face of the demand, more than the perfection in the domain, organizations should focus on obtaining clarity on what exactly is medical writing than being confused with science writing. How both the aspects differ?
Difference between Medical Writing & Science Writing