Below is a list of popular client requests in Regulatory.
Regulatory gap analysis
BLA & MAA section gap analysis and authorship
BLA Module 3 (M3) documentation gap analysis
CMC & preclinical gap analysis to IND & FIH (First in Human, or F-i-H) readiness
Readiness assessments ahead of regulatory submissions
CTA gap analysis
For clinical-specific regulatory details, visit our Clinical Domain page
For nonclinical-specific regulatory details, visit our Nonclinical Domain page
Regulatory strategy
Special designation assistance, including: Regenerative Medicine Advanced Therapy (RMAT), CMC Development And Readiness Pilot (CRPD), Breakthrough Therapy Designation, Fast Track Designation (FTD), Accelerated Approval, Priority Review, Priority medicines scheme (PRIME), Advanced Manufacturing Technology (AMT), Orphan Drug Designation (ODD), Sakigake Designation, Innovative Licensing and Access Pathway (ILAP), Early Access to Medicines Scheme (EAMS)
Information Request (IR) support
PDUFA review cycle support
Regulatory strategy support for the following regulators: USA's Food and Drug Administration (FDA), Canada's Health Canada – Health Products and Food Branch (Health Canada/HC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), France's National Agency for Medicines and Health Products Safety (ANSM), Germany's Federal Institute for Drugs and Medical Devices (BfArM), Spain's Spanish Agency for Medicines and Health Products (AEMPS), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), China's National Medical Products Administration (NMPA; formerly CFDA), South Korea's Ministry of Food and Drug Safety (MFDS; formerly KFDA). Australia's Therapeutic Goods Administration (TGA), New Zealand's Medsafe – New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and Israel's Ministry of Health – Pharmaceutical Administration (MOH / AMAR)
