Faison Associates

Faison Associates is a network of regulatory medical writers, quality control experts, and consultants with decades of combined biopharmaceutical industry experience. The company provides comprehensive medical writing and document development support services for drug and biologics development, spanning clinical through regulatory submission phases.

The team brings cross-functional expertise in clinical research, regulatory affairs, and submission management. Their service portfolio includes clinical document development (protocols, CSRs, investigator brochures), regulatory writing (NDA/MAA/CTD modules, briefing packages, orphan designations), and regulatory strategy consulting. Recent work includes supporting a gene therapy company developing innovative treatments in oncology and hemoglobinopathies.

The leadership team collectively represents over 60 years of pharmaceutical industry experience, with backgrounds spanning laboratory research, clinical operations, medical affairs, and regulatory submission management across both animal health and human therapeutics.

Choose Faison Associates when your biopharmaceutical program requires seasoned regulatory writers who can integrate quickly with existing teams and navigate complex submission requirements. Their network structure allows for scalable support tailored to specific therapeutic areas and document needs.

Expect a consultative approach leveraging decades of pharmaceutical industry experience, with particular strength in regulatory strategy, clinical document development, and submissions for innovative therapies including gene and cell therapy programs.

Faison Associates focuses exclusively on the biopharmaceutical and biotechnology sectors, providing regulatory medical writing for drug and biologics development. Their healthcare expertise centers on clinical trial documentation, regulatory submissions to FDA and EMA, and strategic guidance for navigating global regulatory pathways.

The team has specific experience in oncology, hemoglobinopathies, and gene/cell therapy development, with documented work supporting innovative gene therapy companies. Their services address regulatory compliance requirements specific to pharmaceutical development including ICH guidelines, CTD formatting, and health authority expectations.

Emerging biotech companies and mid-sized pharmaceutical firms developing innovative therapies who need expert regulatory writing support without maintaining full-time internal teams. Organizations preparing for critical regulatory milestones including IND filings, agency meetings, or NDA/MAA submissions where strategic guidance and high-quality documentation are essential.