CAPITAL MEDICAL GROUP

WEBSITE UNDER MAINTENANCE 7 - 31 AUGUST 2025.
NO WEBSITE FUNCTIONS AVAILABLE DURING THIS TIME.

MEDICAL CONSULTING

Under Maintenance

MEDICOLEGAL CONSULTING

Under Maintenance

PHARMACEUTICAL MEDICAL AND REGULATORY AFFAIRS

Under Maintenance

MEDICAL WRITING

Under Maintenance

MEDICAL AVIATION

Under Maintenance

MEDICAL CONSULTING

Expert Care, Honest Guidance

  • Acute Care

  • Chronic Care

  • Preventative Care

  • Urgent Care (No Emergencies)

  • Teleconsultations

  • Wound Care

  • Surgical Procedures

MEDICOLEGAL CONSULTING

Independent Medical Insight. Trusted Legal Outcomes.

At the intersection of medicine and law, we provide clear, reliable medico-legal expertise to legal professionals, insurers, and healthcare institutions.Our mission is to translate complex medical information into legally actionable insights—improving the quality of legal arguments and outcomes.

Medico-Legal Case Reviews

We assist legal professionals by reviewing medical records and clinical documentation to support or challenge claims.

  • Medical Negligence Litigation

  • Road Accident Fund (RAF) claims

  • Personal injury and trauma cases

  • Worker’s compensation and disability claims

  • Delayed diagnosis and wrongful death claims

  • Wrongful accusations against healthcare workers or institutions

PHARMACEUTICAL MEDICAL AND REGULATORY AFFAIRS

Scientific Integrity. Strategic Precision. Regulatory Peace of Mind.

Regulatory and Medical Affairs for South African Pharmaceutical Companies.

As South Africa’s pharmaceutical and healthcare sectors evolve, efficient and compliant execution of Regulatory and Medical Affairs functions has never been more critical. We provide end-to-end outsourcing solutions for pharmaceutical, biotech, and medical device companies—designed to meet the complex requirements of the South African Health Products Regulatory Authority (SAPHRA), regional initiatives such as ZaZiBoNa, and global best practices.We offer scalable support across all commonly outsourced departments, helping companies reduce operational burden while enhancing scientific integrity, market readiness, and patient access.

Regulatory Affairs Services

  • Regulatory strategy for NCEs, generics, biologics, biosimilars, and complementary medicines

  • eCTD dossier preparation, submission, and life-cycle maintenance (variations, renewals)

  • SAPHRA and regional health authority liaison, meeting preparation, and response management

  • Professional Information (PI), Patient Information Leaflet (PIL), and artwork development

  • Regulatory intelligence, competitor tracking, and local market entry guidance

Medical Affairs Services

  • Country-level medical affairs strategy aligned with brand and clinical objectives

  • Key Opinion Leader (KOL) mapping, engagement planning, and advisory board coordination

  • Medical review of promotional materials (PIASA/SAMED-compliant MLR support)

  • Medical information services, including standard response letter (SRL) creation and query handling

  • Scientific content development: slide decks, training modules, disease awareness materials

Pharmacovigilance Support

  • Collection and processing of Individual Case Safety Reports (ICSRs)

  • Aggregate report development (PSURs, DSURs, RMPs)

  • Signal detection and benefit-risk assessments

  • Support for QPPV activities, PV system setup, and SAPHRA PV submissions

Medical Writing & Scientific Communications

  • Clinical documents: protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs)

  • Regulatory documents: Module 2/5 content for SAPHRA submissions

  • Publications: manuscripts, posters, abstracts, and slide decks

  • Congress preparation and medical communications for local and regional events

Market Access & Health Economics

  • Health Technology Assessment (HTA) dossier preparation for private and public payers

  • Budget impact models and pharmacoeconomic evaluations

  • Real-world evidence (RWE) strategy and data generation

  • Strategic support for formulary listing and reimbursement applications

Clinical Operations & Ethics Submissions

  • SAPHRA and ethics committee (HREC) submissions

  • Feasibility assessment and protocol adaptation

  • Site selection, investigator engagement, and startup logistics

Quality, Compliance & Audit Readiness

  • Internal and supplier GxP audits

  • SOP development, training, and implementation

  • Data integrity, documentation control, and pre-inspection preparation

Why Partner With Us?

Partnering with us means gaining a trusted ally with proven expertise in the South African regulatory and medical landscape. We bring deep, hands-on knowledge of SAPHRA requirements, ZaZiBoNa processes, and regional compliance frameworks, ensuring your product journey is both efficient and compliant. Our multidisciplinary team—comprising regulatory professionals, medical writers, pharmacovigilance experts, and clinical scientists—offers integrated support across every stage of development and commercialization. Whether you require full-function outsourcing, project-specific assistance, or strategic consultancy, our flexible engagement models are designed to meet your unique business needs. Above all, we are committed to scientific accuracy, ethical integrity, and delivering patient-centered outcomes that align with both local standards and global expectations.

MEDICAL WRITING

From Molecule to Market - We Write What Matters

We translate science into strategy, compliance into clarity, and data into decisions.

We are a full-service medical writing firm that empowers pharmaceutical innovators, healthcare institutions, insurance providers, and public health leaders with writing that delivers results.Our team of professionals brings together deep scientific knowledge, regulatory fluency, and strategic communication expertise. From regulatory submissions and clinical trial documents to plain-language summaries and health funder dossiers—we deliver precision with purpose.

Who We Serve

  • Pharmaceutical and Biotechnology Companies

  • Contract Research Organizations (CROs)

  • Hospital Groups and Health Systems

  • Healthcare Funders and Insurance Providers

  • Public Health Agencies and NGOs

  • Patients, Caregivers and the General Public

Our Medical Writing Services

Regulatory Medical Writing

  • Clinical Study Protocols (CSPs)

  • Clinical Study Reports (CSRs)

  • Investigator’s Brochures (IBs)

  • Informed Consent Forms (ICFs)

  • Patient Narratives

  • Common Technical Document (CTD) Modules 2 & 5

  • Risk Management Plans (RMPs)

  • Briefing Books & Meeting Packages

  • Regulatory Authority Responses (FDA, EMA, SAHPRA, PMDA)

  • IND / NDA / BLA / IMPD Submissions

  • Periodic Safety Update Reports (PSURs, PBRERs)

Scientific and Clinical Publications

  • Scientific and Clinical Publications

  • Manuscripts for Peer-Reviewed Journals

  • Abstracts, Posters, and Slide Decks

  • Systematic and Narrative Literature Reviews

  • Clinical Trial Results Summaries

  • Real-World Evidence (RWE) Studies

  • Scientific Platform & Communication Strategy

Medical Communications & Education

  • Scientific Narratives & Product Value Stories

  • Advisory Board & KOL Engagement Materials

  • HCP Training Modules & eLearning Content

  • Sales Training & Medical Affairs Tools

  • Mechanism of Action (MoA) Visuals & Storyboards

  • MSL Slide Decks & Speaker Briefs

Health Economics, Market Access & Reimbursement

  • Global Value Dossiers (GVD)

  • AMCP Dossiers (US Payers)

  • HTA Submissions (NICE, CADTH, EUnetHTA, etc.)

  • Cost-Effectiveness Summaries

  • Budget Impact Models

  • Reimbursement Application Support

  • Payer Communication Tools

Pharmacovigilance & Safety Writing

  • Development Safety Update Reports (DSURs)

  • Periodic Adverse Drug Experience Reports (PADERs)

  • Pharmacovigilance System Master Files (PSMFs)

  • Signal Detection Reports & Risk Assessments

  • Aggregate Safety Reports

  • Individual Case Safety Narratives

Hospital & Health System Support

  • Clinical Guidelines & Pathways Documentation

  • Quality Improvement Reports

  • Health Technology Assessments (HTA)

  • Continuing Medical Education (CME) Modules

  • Audit Summaries & Clinical Performance Reports

  • Medical Policy Drafting & Protocols

Healthcare Funders & Insurance

  • Healthcare Funders & Insurance Providers

  • Medical Necessity Guidelines

  • Claims Review Medical Summaries

  • Evidence-Based Policy Documentation

  • Health Plan Member Communication

  • Utilization Review Documentation

Patient, Lay & Public-Facing Content

  • Patient Information Leaflets (PILs)

  • Plain Language Summaries (PLS) of Clinical Trials

  • Health Literacy-Compliant Brochures

  • Digital & Web Copy for Patient Engagement

  • Multilingual Health Education Materials

  • Public Awareness Campaign Content

Why Partner With Us?

At Capital Medical Group, we deliver expert medical writing services that speak fluently to regulators, clinicians, payers, and patients alike. Our team combines deep therapeutic area expertise—from oncology and cardiology to rare diseases and mental health—with a mastery of global regulatory frameworks including ICH, GCP, FDA, EMA, SAHPRA, and PMDA. Every document we produce undergoes rigorous, end-to-end quality control to ensure scientific accuracy, clinical relevance, and compliance. Whether supporting a single submission or managing a global portfolio, we provide scalable, secure solutions tailored to pharmaceutical companies, CROs, hospital groups, and healthcare funders. Our writing turns complex science into clear, actionable communication—ready for regulatory review, publication, or patient education.

MEDICAL AVIATION

Because Every Life Deserves a Flight Plan.

Built for business. Ready for rescue.

In critical moments, every second matters. The Medical Aviation Department delivers exclusive, mission-ready medevac services for corporate clients only — ensuring your personnel receive rapid, expert medical transport when emergencies strike, no matter where business takes them.

Purpose-Built for Corporate Risk Profiles

Unlike general medevac providers, our services are custom-designed to support corporate operations across high-risk, high-demand sectors. Our aircraft, medical teams, and deployment protocols are engineered to align with your duty of care, operational continuity, and employee wellbeing strategies.

  • Exclusive Contracts – We serve corporate clients only, ensuring guaranteed availability.

  • Rapid Response – From call to airborne in under 90 minutes.

  • Integrated Solutions – Real-time reporting, HR coordination, and compliance documentation.

  • Medical Excellence – ICU-capable in-flight care with advanced critical care teams.

Global Coverage. Local Precision.

With a fleet positioned across continents and medevac crews on standby 24/7, we provide true global reach with tailored local execution. Whether your employees are in remote mines, offshore installations, or frontier markets — we’re their way home.

Our Fleet. Their Lifeline.

  • Learjet 45/75 | Challenger 604 |

  • Airbus H145 | Bell 429

  • Medically equipped with onboard ICU, ventilators, advanced cardiac support, and satellite comms.

Every aircraft is staffed by flight physicians, critical care nurses, and paramedics trained in high-acuity extraction and in-flight stabilization.

We understand the sensitivity of executive and workforce evacuations. Our protocols ensure complete discretion, data security, and regulatory compliance — while delivering elite medical care at speed.

Who We Serve

  • Mining and energy companies

  • Global construction & infrastructure firms

  • Financial institutions with overseas branches

  • Remote logistics and exploration operations

  • Multinational corporates with workforce exposure in high-risk regions