Navigating the changing regulatory landscape is an ongoing challenge for many involved in the development, approval, and manufacture of pharmaceuticals drug products.

The Upperton Pharmaceuticals Regulatory Affairs team is here to guide and assist pharmaceutical and biotech companies in the design and implementation of innovative and global regulatory strategies to expedite product development and registration of drugs, biologics and combination products for all stages of development (preclinical to post-marketing approval).

Our Regulatory Support Services span the following phases of your products development pathway:

Clinical Trials

• Writing or review of Investigator Brochure and IMPDs including CMC, non-clinical and clinical sections, clinical protocols.
• INDs/CTAs and amendmentspreparation & submission
• DSURs, Annual Safety reports preparation & submission

Regulatory Strategy, Gap Analysis & Classifications

• Drugs, Biologics, OTC Products, Combination Products
• Development plans, Gantt charts
• Gap analysis for “reborn” projects and / or during due diligence

Regulatory Agency Interactions Support

• Scientific Advice, Pre-IND, EOP2 meetings, pre-NDA/BLA meetings, Protocol assistance
• Orphan Drug Status designation EU & US
• ATMP classification
• PRIME designation, Fast track designation, breakthrough therapy designation

Marketing Applications

• MAA / NDA / ANDA / BLA