Masuu provides inclusive regulatory services (Regulatory Affairs, Regulatory Operations, Labeling and Clinical) to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare, CMO and Medical Device industry and we are dealing with regulated and semi regulated markets during product development phase, product registration phase and product launch / commercialization phase.
Masuu Regulatory Affairs qualified expertise team has specialization in regulatory planning and strategy during product development stage, pre and post approval submission gap analysis, quality filing and compliance, submission content writing, review, compilation and validation of final dossier for various types of applications throughout the globe.
Masuu Regulatory Affairs team has expertise in pre (original application, amendment to original application) and post approval (variations / supplement, annual report and PSUR / PADER) submission for US, Europe, Canada and Gulf;
For different country
USFDA
- Investigational New Drug (IND)
- Abbreviated New Drug Application (ANDA) – 505 (J)
- Biological License Application (BLA)
- New Drug Applications (NDA) / (505 b(2))
- Drug Master File (DMF Type II, III and IV)
- Medical Devices – 505 (k)
Health Canada
- New Drug Submission (NDS)
- Supplement to a New Drug Submission (SNDS)
- Abbreviated New Drug Submission (ANDS)
- Supplement to an Abbreviated New Drug Submission (SANDS)
- Clinical Trial Application (CTA)
EU-EMA
- Marketing Authorization Applications (MAA) via Centralized, National, Mutual Recognition and Decentralized Procedure
- Active Substance Master Files (ASMF)
- CEP Submissions
Gulf Countries
- Marketing Authorization Applications (MAA) for Biological, Generic and New chemical Entity via National and GCC Procedure