The Global Medical Affairs & Medical Writing Consultancy

Services Offered

Pharmacovigilance:

• Evaluation of safety data (drug safety physicians with more than 25 years industry experience)
• Serious adverse event narratives (SAEs)
• Serious adverse event (SAEs) data management
• Writing/review of periodic safety reports (PSUR)
• Writing/review of quarterly and annual safety reports
• Investigator brochures
• Product safety/pharmacovigilance  leadership by experience physicians
• Case causality assessment

Regulatory Affairs/Regulatory Writing/Regulatory Submission Services:

• Writing/review of all clinical documents needed to file drugs and medical device in the US/EU
• Clinical expert reports (CER) for medical device
• Pre-clinical expert reports
• Clinical and pre-clinical overviews
• Clinical summaries
• Writing of standard operating procedures (SOPs)
• Prescribing/labelling review

Clinical Trials Design/Execution Services:

• Clinical leadership
• Line management
• Supervision of clinical project progress
• Study protocols (Phase I-IV)
• Case report forms (CRF)
• Investigator brochures and annual safety updates
• Informed consents
• Applications to respective ethics committees
• Clinical Study reports (CSR)
• Post marketing surveillance
• Medical support/Advice/monitoring/review for trails (stage I-IV) by experience physicians
• Leading & medical/safety management of trials by experience physicians  (stage I-IV)
• Advisory board leadership
• Clinical development medical support
• Narratives (writing and review)

Intelligence Services:

• Regulatory Intelligence
• Competitor Intelligence
• KOL Intelligence
• Product Intelligence
• Market Intelligence

Medical Writing/Communication Services:

• Congress services/reporting
• Journal articles
• Manuscripts
• Case reports
• Grants
• Abstracts
• Posters
• Slide decks
• Medical book chapters
• Literature reviews
• Presentations
• Brochures
• Newsletters
• Review articles
• Editing
• Proof reading
• Publication planning

Marketing Services:

• Marketing support activity (writing/review) for all new pipeline drugs and medical device
• Market research for the major global pharmaceutical markets
• Development of product/drug dossier and compendia
• Website Development
• Search Engine Optimization
• Social Media Marketing
• Ad words Campaigns
• Print Collateral (product brochures, sales kits, etc.)
• Trade and Consumer Ads
• Email Campaigns
• Blog Development and Content
• Public Relations (online and traditional)
• Intelligence Services:
  • Competitor intelligence
  • Product intelligence
  • Publication/literature intelligence
  • Key opinion leader (KOL) intelligence
• Continuing Medical Education (CME):
  • Sale force training (Pharmaceutical/medical device sales representatives, Medical science liaison):
    • E-learning
    • Self-training modules
    • Educational monographs/presentations
    • Job aids
  • Patients:
    • Health information systems
    • Information brochures
    • Digital patient information systems