Regulatory Medical Writing

End-to-End Medical Writing Services for Global Clients

CONTINUUM offers high-quality and compliant medical writing services across the entire drug development cycle (preclinical, clinical & commercial). We have expertise across a broad category of therapeutic areas and document types. We also offer medical writing services for medical devices and medical technologies considering the EUMDR & USFDA requirements.

Medical Writing Services:

Clinical Writing:

To support high-quality clinical deliverables that are ICH GCP compliant and scientifically informed

      • ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV
      • CSR Synopses for public disclosure
      • Investigator Brochures
      • Study Protocols
      • Patient information & Informed Consent
      • Lay summaries
      • Patient Brochures

Regulatory Writing:

To deliver first time-right Regulatory submissions in a timely manner

      • Investigational new drug applications (INDs), new drug applications (NDAs), and common technical document (CTD) submission dossiers
      • Regulatory responses
      • Clinical and non-clinical overviews
      • Summary of product characteristics & core data sheets
      • Clinical expert statements
      • Briefing documents
      • Labelling compliance assessment

Pharmacovigilance Writing:

To ensure benefit-risk reporting per regulatory and clinical standards

      • Periodic safety update reports (PSURs)
      • Periodic benefit-risk evaluation reports (PBRERs)
      • US Food and Drug Administration periodic line listings
      • Risk management plans (RMPs)
      • Development safety update reports (DSURs)
      • Local safety summaries (LSSs)
      • Signal analyses

Medical Communications:

To ensure all the commercial objectives have valid scientific relevance

      • Medical communication including manuscripts, conference abstracts/posters, product website content, educational material for HCPs and patients
      • Medical marketing reviews and reports
      • Slide kits for internal/external communication

Medical writing for Medical Devices & Medical Technologies:

To address all medical device & technology-specific regulatory writing objectives particularly relevant to EUMDR transition and emerging USFDA guidelines

      • Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, and Summary of Safety and Clinical Performance (SSCP) reports in support of EU MDR compliance, feasibility reports, guided questionnaires, and labeling documents

Our Services

Dedicated Customer Teams & Agile Services

Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.