Medical Affairs & Medical Writing

Pharmaceutical Medical Affairs Consulting and Medical Writing

Pharmaceutical Medical Affairs Consulting

Medical affairs is among the most complex and intimidating disciplines, which is why pharma and biotech companies are often searching for specific expertise to help them in this area. Many of these enterprises find that GForce Life Sciences is the partner they need. They appreciate our steady hand that guides them through these challenges.

We provide medical affairs pharma consulting that is designed to help your company communicate more effectively with providers, thought leaders and stakeholders throughout the healthcare sector.

Unlike many of our competitors, our attention is entirely on the life sciences industries. This means that we have a laser-focused understanding of the challenges you face with these issues. Our industry-specific concentration means we will provide the medical affairs consulting services and solutions that are right for your business.

Medical Affairs Consulting Capabilities

Our services cover virtually all aspects of the process. Pharma companies receive medical communications consulting with respect to:

  • Portfolio and Asset Lifecycle Management
  • Study Design
  • Epidemiology
  • Patient Assessment

We Have a Network of Skilled Medical Writers

GForce Life Sciences knows that quality is the most important factor in producing any document. Our highly experienced network of medical writers is committed to providing you with clear and concise documents that are sound from both a scientific and a regulatory perspective.

GForce’s team has authored countless Clinical Study Reports (CSRs), clinical protocols, Investigator Brochures (IBs) and components of Investigational New Drug (IND) applications. We have extensive experience writing the clinical components of marketing applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the U.S. and Marketing Authorization Applications (MAAs) in Europe.

Medical Writing Services

Our team has significant experience authoring a variety of regulatory documents across a wide range of therapeutic areas and all phases of development, including:

  • Marketing Applications
  • Integrated Summaries of Efficacy (ISE) and Safety (ISS) for U.S. Submissions
  • Clinical Components of Common Technical Document (CTD) (Module 2): Clinical Overview (Module 2.5); Summary of Clinical Efficacy (Module 2.7.3); and Summary of Clinical Safety (Module 2.7.4)
  • Nonclinical and Clinical Pharmacology Summaries and Overviews
  • CSRs & Clinical Protocols (across all phases of development)
  • INDs and IND Amendments
  • Orphan Drug Applications and Annual Reports
  • Investigator Brochures
  • Clinical Protocols and Amendments
  • Safety Narratives
  • Development Safety Update Reports (DSURs)
  • IND and NDA Annual Reports
  • Regulatory Agency Briefing Documents
  • Advisory Committee Briefing Packages
  • Pediatric Study Plans (U.S.)
  • Document Quality Assurance
  • Regulatory Documents (CMC, Clinical and Nonclinical)
  • Document Development SOPs
  • Submission Document Management

 “I have to tell you, I am impressed with your ability to present new consultants promptly. I haven’t seen anything like it before.”

— Vice President of Clinical Affairs, Global Pharmaceutical Manufacturer

Learn how GForce Life Sciences can help accelerate your growth.