The Write Source MSC, LLC

The Write Source MSC, LLC provides medical, scientific, and regulatory writing services to pharmaceutical companies, biotech firms, medical device manufacturers, medical communications agencies, and government entities. The company delivers specialized writing across the drug development lifecycle, from preclinical studies through post-marketing research.

The firm's capabilities span three core areas: medical writing and editing (patient education, sales training, promotional materials, CME content), regulatory writing (eCTD submissions, INDs, NDAs, clinical study protocols and reports, medical device documentation), and scientific publications (congress abstracts, manuscripts, posters, systematic reviews). Their client portfolio includes major pharmaceutical companies like Pfizer and Janssen, medical communications agencies such as Ashfield and Lumanity, and government agencies including NIH NIDDK.

The Write Source MSC emphasizes adherence to industry guidelines and ethical standards in medical communications. Their approach focuses on conveying complex medical and scientific content clearly to appropriate audiences, whether healthcare professionals, regulatory reviewers, or patients.

Organizations should consider The Write Source MSC when they need experienced medical writers who understand pharmaceutical regulatory requirements and publication standards. The firm's work with major pharmaceutical companies and government agencies indicates capability handling complex, high-stakes documentation.

Clients can expect writers who follow Good Publication Practice guidelines and maintain awareness of evolving regulatory requirements. The company's breadth of services makes them suitable for organizations needing support across multiple document types within a single engagement.

The Write Source MSC operates exclusively in healthcare, specializing in the pharmaceutical, biotech, and medical device sectors. Their work directly supports drug development regulatory compliance, clinical trial reporting, and scientific communication within the healthcare industry.

The firm's healthcare expertise encompasses therapeutic area knowledge, familiarity with FDA and EMA requirements, understanding of clinical trial design and reporting standards (ICH-E3), and adherence to medical publication ethics guidelines (GPP3, ICMJE). Their client base spans pharmaceutical manufacturers, CROs, medical communications agencies, and healthcare-focused government agencies.

Pharmaceutical and biotech companies in clinical development phases requiring regulatory documentation support, medical communications agencies seeking specialized freelance writers for client projects, and medical device companies preparing CER reports and validation documentation. Organizations valuing writers with deep regulatory knowledge and publication experience.