Medical Writing Services
Expert scientific documentation for regulatory submissions, clinical research, and scientific communications
Our Medical Writing Services
Clinical Study Reports
Comprehensive clinical study reports meeting ICH E3 guidelines and regulatory requirements
- Phase I-IV clinical study reports
- Integrated summaries of efficacy and safety
- Statistical analysis plan documentation
- Data listing and patient narratives
Regulatory Submission Documents
Expert preparation of regulatory dossiers and submission documents for global markets
- Common Technical Document (CTD) modules
- Marketing Authorization Applications
- Clinical Trial Applications
- Variation and lifecycle management documents
Scientific Publications
High-quality manuscripts for peer-reviewed journals and scientific conferences
- Research articles and case studies
- Review articles and meta-analyses
- Conference abstracts and posters
- Editorial and commentary pieces
Clinical Development Documents
Strategic documents supporting clinical development planning and execution
- Clinical development plans
- Investigator brochures
- Clinical study protocols
- Informed consent forms
Patient Information Materials
Clear, accessible patient-facing documentation ensuring informed participation
- Patient information leaflets
- Informed consent documents
- Patient reported outcome measures
- Educational materials and brochures
Safety Documentation
Comprehensive safety documentation for pharmacovigilance and risk management
- Periodic Safety Update Reports (PSUR)
- Risk Management Plans (RMP)
- Development Safety Update Reports (DSUR)
- Signal detection and assessment reports
Regulatory Document Portfolio
CTD Module 2
Overviews & Summaries
- Quality Overall Summary (QOS)
- Nonclinical Overview
- Clinical Overview
- Nonclinical Summary
- Clinical Summary
CTD Module 3
Quality Documentation
- Drug substance documentation
- Drug product documentation
- Pharmaceutical development
- Manufacturing information
- Control of drug substance/product
CTD Module 4
Nonclinical Study Reports
- Pharmacology studies
- Pharmacokinetic studies
- Toxicology studies
- Special studies
- Literature references
CTD Module 5
Clinical Study Reports
- Tabular listings of clinical studies
- Clinical study reports
- Literature references
- Postmarketing experience
- Case report forms
Medical Writing Standards & Guidelines
Our medical writing services adhere to the highest industry standards and international guidelines, ensuring regulatory compliance and scientific excellence.
ICH Guidelines
- ICH E3 - Clinical Study Reports
- ICH E6 - Good Clinical Practice
- ICH M4 - Common Technical Document
- ICH E9 - Statistical Principles
Professional Standards
- EMWA Guidelines
- AMWA Standards
- GPP3 Guidelines
- CONSORT Statement
Regulatory Compliance
Scientific Accuracy
Clear Communication
Quality Assurance
Our Medical Writing Process
1
Project Planning
Comprehensive project scoping, timeline development, and resource allocation
- Document scope definition
- Regulatory requirement analysis
- Timeline and milestone planning
- Quality assurance planning
2
Research & Data Analysis
Thorough data review and scientific literature analysis
- Clinical data review and analysis
- Literature search and evaluation
- Statistical analysis interpretation
- Regulatory guidance review
3
Document Development
Expert writing and structured document development
- First draft preparation
- Scientific accuracy review
- Regulatory compliance check
- Internal quality review
4
Review & Finalization
Comprehensive review process and final document preparation
- Client review and feedback
- Expert medical review
- Final revisions and formatting
- Quality assurance and delivery
Comprehensive Medicine Coverage
Our medical writing expertise spans all categories of medicines and therapeutic interventions, ensuring specialized knowledge for every project.
Small Molecule Drugs
🧪 Chemical Entities
- New Chemical Entities (NCEs)
- Generic pharmaceuticals
- Fixed-dose combinations
- Modified-release formulations
- Oral solid dosage forms
- Injectable formulations
- Topical preparations
💊 Therapeutic Classes
- Analgesics and pain management
- Antibiotics and antimicrobials
- Antiviral medications
- Cardiovascular drugs
- CNS and psychiatric medications
- Endocrine and metabolic drugs
- Oncology therapeutics
Biological Medicines
🧬 Protein Therapeutics
- Monoclonal antibodies
- Recombinant proteins
- Enzymes and enzyme replacement therapies
- Hormones and growth factors
- Cytokines and interferons
- Fusion proteins
- Antibody-drug conjugates (ADCs)
🩸 Blood Products
- Plasma-derived medicines
- Immunoglobulins
- Coagulation factors
- Albumin products
- Hyperimmune immunoglobulins
Advanced Therapy Medicinal Products (ATMPs)
🧬 Gene Therapies
- In vivo gene therapy
- Ex vivo gene therapy
- Gene editing (CRISPR/Cas9)
- Viral vector-based therapies
- Non-viral gene delivery
- RNA therapeutics (siRNA, mRNA)
- Antisense oligonucleotides
🔬 Cell Therapies
- CAR-T cell therapies
- Stem cell therapies
- Tissue-engineered products
- Somatic cell therapies
- Immunotherapy cells
- Regenerative medicine
Vaccines & Immunological Products
💉 Vaccine Types
- Live attenuated vaccines
- Inactivated vaccines
- Subunit vaccines
- mRNA vaccines
- Viral vector vaccines
- Conjugate vaccines
- Therapeutic vaccines
🛡️ Immunological Products
- Allergen products
- Immunostimulants
- Immunosuppressants
- Diagnostic agents
- Radiopharmaceuticals
Medical Devices & Combination Products
🔧 Device Categories
- Drug-device combinations
- Implantable devices
- Diagnostic devices
- Therapeutic devices
- Software as Medical Device (SaMD)
- AI/ML medical devices
- Digital therapeutics
💊 Combination Products
- Pre-filled syringes
- Auto-injectors
- Inhalers and nebulizers
- Transdermal patches
- Drug-eluting stents
- Implantable drug pumps
Specialized Medicine Categories
🌿 Natural Products
- Herbal medicinal products
- Traditional medicines
- Well-established use products
- Botanical drug products
- Homeopathic medicines
🧪 Specialized Formulations
- Orphan medicinal products
- Pediatric formulations
- Geriatric-specific medicines
- Personalized medicines
- Companion diagnostics
- Radiopharmaceuticals
- Controlled substances
Therapeutic Area Expertise
🧠 Neuroscience
- Alzheimer's disease
- Parkinson's disease
- Multiple sclerosis
- Epilepsy and seizure disorders
- Depression and anxiety
- Schizophrenia and bipolar disorder
- Migraine and headache disorders
- Stroke and cerebrovascular disease
🧬 Oncology
- Solid tumors (lung, breast, colorectal)
- Hematological malignancies
- Immunotherapy and checkpoint inhibitors
- Targeted therapy and precision medicine
- CAR-T cell therapy
- Pediatric oncology
- Rare cancers and sarcomas
- Supportive care and palliative medicine
❤️ Cardiovascular
- Heart failure and cardiomyopathy
- Coronary artery disease
- Arrhythmias and electrophysiology
- Hypertension and lipid disorders
- Thrombosis and anticoagulation
- Valvular heart disease
- Peripheral artery disease
- Congenital heart disease
🦠 Infectious Diseases
- Antimicrobial resistance
- Viral infections (HIV, HCV, influenza)
- Bacterial and fungal infections
- Vaccine-preventable diseases
- Tropical and neglected diseases
- Hospital-acquired infections
- Immunocompromised patients
- Pandemic preparedness
🩺 Endocrinology
- Diabetes mellitus (Type 1 & 2)
- Obesity and metabolic syndrome
- Thyroid disorders
- Adrenal and pituitary disorders
- Osteoporosis and bone health
- Growth hormone disorders
- Reproductive endocrinology
- Rare endocrine diseases
🫁 Respiratory
- Asthma and allergic diseases
- Chronic obstructive pulmonary disease
- Idiopathic pulmonary fibrosis
- Pulmonary arterial hypertension
- Cystic fibrosis
- Sleep disorders
- Lung cancer
- Respiratory infections
🦴 Musculoskeletal
- Rheumatoid arthritis
- Osteoarthritis
- Systemic lupus erythematosus
- Ankylosing spondylitis
- Psoriatic arthritis
- Osteoporosis
- Fibromyalgia
- Rare bone diseases
👁️ Ophthalmology
- Age-related macular degeneration
- Diabetic retinopathy
- Glaucoma
- Dry eye disease
- Retinal vein occlusion
- Inherited retinal diseases
- Uveitis and inflammatory conditions
- Refractive surgery
🧪 Rare Diseases
- Genetic disorders
- Metabolic diseases
- Lysosomal storage disorders
- Hemoglobinopathies
- Primary immunodeficiencies
- Neuromuscular disorders
- Orphan cancers
- Ultra-rare conditions
👶 Pediatrics
- Neonatal medicine
- Pediatric oncology
- Congenital disorders
- Developmental disorders
- Pediatric infectious diseases
- Growth and development
- Adolescent medicine
- Pediatric surgery
Transform Your Scientific Data into Compelling Documentation
Partner with our medical writing experts for regulatory-ready documents that drive approval success