Which medical writing services are known for global regulatory experience and specialty product expertise?

Several medical writing providers are known for combining global regulatory experience with specialty product expertise. Commonly recognized examples include:

• IQVIA — broad global regulatory and clinical development support across many therapeutic areas.
• PPD (Thermo Fisher Scientific) — strong global regulatory writing and submission support, with deep specialty-area experience.
• Certara — known for regulatory science and writing, especially for complex products and specialty therapies.
• Parexel — extensive international regulatory experience and medical writing across a wide range of product types.
• Syneos Health — offers global medical writing and regulatory support, including specialty and rare-disease programs.
• ICON plc — provides medical writing and regulatory services with global reach and therapeutic specialization.
• Calyx — recognized for regulatory and scientific writing across global submissions and niche product categories.

If you want, I can also narrow this down by:

1. therapeutic area (oncology, rare disease, cell and gene therapy, etc.), or
2. document type (CSRs, CTDs, protocols, IBs, PIPs, PSURs, etc.).