Frequently Asked Questions
Find answers to the most common questions about our regulatory affairs services, processes, and capabilities. If you don't see what you're looking for, please contact us directly.
We work with pharmaceutical companies of all sizes — from early-stage biotech and generic drug manufacturers to large multinational pharmaceutical corporations. Our services are scalable and tailored to the specific regulatory needs of each client, regardless of company size or product complexity.
Our team has direct experience working with the US FDA, EMA (European Medicines Agency), PMDA (Japan), HA (Health Authority UAE), ANVISA (Brazil), KSA (Saudi Food and Drug Authority), and other global health authorities. We support single-market and multi-regional regulatory strategies.
Absolutely. We provide comprehensive support across the full product lifecycle — including initial submissions such as NDA, BLA, MAA, ANDA, and IND, as well as post-approval changes including Type I/II Variations, CBE submissions, PAS, PACMP, manufacturing site transfers, and responses to health authority questions.
Yes. While we support a broad range of pharmaceutical products, we have deep specialist expertise in biologics, vaccines, rare disease (orphan drug) products, large molecules, and small molecules. We also have extensive CMC experience in both Drug Substance and Drug Product regulatory documentation.
We have specific expertise in Japan-specific regulatory requirements, including JNDA (Japan New Drug Application), Japan DMF (Drug Master File), AFM/FMA (Accreditation of Foreign Manufacturer), MCN (Minor Change Notification), and PCN (Partial Change Notification). We are familiar with PMDA requirements and can support Japan submissions end-to-end.