Medical Writing

At large, medical writing involves writing well-structured documents that include clinical research findings, content for journals, healthcare websites and magazines, and news channels. Regulatory medical writing involves authoring documents for regulatory agencies for approval of devices, drugs, and biologics, including clinical data, submission documents, and post-approval documents.

With time, regulatory medical writing has become more complex. The introduction of new laws for drug approval and administration necessitates the guidance of experts in biostatistics, clinical trial management, scientific scholars, and regulatory affairs.
Regulatory medical writers can assist in authoring regulatory submission ready documents, data interpretation, protocol design, product labelling, and process improvement. At Scicare, we translate and summarise complex statistical and scientific data for the client. We provide valuable insight into certain aspects of the study, with appropriate quality control.

At Scicare Life Sciences Services Pvt. Ltd., we provide extensive regulatory medical writing services.

We author a variety of reports and writings, covering Novel drugs, generics, biologics, medical devices, and consumer care products. These include –

● Investigational Medicinal Product Dossier (IMPD)
● Investigator Brochures (IB)
● Common Technical Document (CTD)
● Clinical Study Reports (CSR)
● Periodic Safety Update Reports (PSUR)
● Company Core Data Sheets (CCDS)
● Pediatric Use Marketing Authorisations (PUMA)
● Risk Management Plans (RMP)
● Labelling regulatory papers – Summary of Product Characteristics (SmPC)
●  An integrated summary of efficacy and safety
● Chemistry, Manufacturing, and Controls (CMC), non-clinical and clinical reports for Novel Molecules (NCEs & NBEs) and approved products

At Scicare, we believe in providing the highest service quality. Our writers have the following skills –

● Writing Clarity and Thought
● Expectation Management
● Consistency
● Mediation
● Listening, Asking, and Persuasion
● Transferable skills from medical writing to regulatory affairs

We offer support for outsourced medical writing. We provide reports ready for submission to regulatory authorities around the world. It includes the FDA in the United States of America, Health Canada in Canada, the European Medicines Agency in the European Union, Ministry of Health, Labour and Welfare in Japan & ROW (Rest of the World). We prepare briefing documents keeping in mind the rules and regulations of each agency.

Regulatory compliance is essential in our industry. We ensure to follow all the regulations and laws prescribed for regulatory medical writing and provide submission-ready documents to our clients.

We aim to be one of the leading consultancy and be valued partners to biopharmaceuticals with our passion to provide excellent service delivery with a unique blend of science and care.

Our goal lies in providing excellent services with care, integrity, and prompt delivery. Our team is available to answer your queries and guide you through the complex process of medical writing. We simplify the technicality of the process and provide you with a comprehensive and unbiased document report.

If your regulatory research report has a high quality of work, with a thorough summary of your clinical trial, it is easier to receive approval from the regulatory bodies. Poorly presented regulatory documents delay it and cost you time and money.

With the increasing complexity of regulations in research and development, life science and healthcare organizations require expert pharma consultancy to achieve effective solutions.  At Scicare, we provide a one-stop solution for regulatory writings, mapping strategies and execute operations seamlessly.

At Scicare, we aim to integrate the technicality of science with the essence of care. Our core principles lie in integrity, quality, and perseverance. With regulatory evolution, we continue to update and improve ourselves in the industry.

Contact us and get your regulatory medical writing services today!