Raaj Global Pharma Training & Training Center is a well-known Training & Educational Centre; based at Mumbai-Thane. We are engaged in conducting various Fast Track and distance learning programmes. Our courses are designed as per the current industrial norms, rules & regulations. We offer Diploma, Advanced PG Diploma & Certificate courses for working professionals, Science & Pharmacy graduates, P
ost-graduates etc. at a very economical rates. We have our expertise in following courses:
1. Category I: 6m Advanced PG Diploma in Drug Regulatory Affairs (Formulations)
2. Category II: 6m Advanced PG Diploma in Drug Regulatory Affairs (API)
3. Category III: 4m Certification course in CTD and eCTD in Formulation
4. Category IV: 4m Certification course in CTD and eCTD in API
5. Category V: 4m Certification course in Quality Assurance & Quality Management
6. Category VI: 4m Certification course in Clinical Research
7. Category VII: 3m Certification course in Pharmaceutical Documentation
8. Category VIII: 3m Certification Course in Pharmacovigilance (NEW COURSE LAUNCHED)
9. Category IX: 6m Advanced PG Diploma in Patents laws & Procedures
10. Category X: 1yr PG Diploma in Pharmaceutical Management
ELIGIBILITY: B.Pharm/M.Pharm/PhD/B.Tech/M.Tech/B.Sc/M.Sc/Biotech/RA/QA/ Clinical Professionals /BAMS/BHMS /BDS/MDS/MBBS/MD etc.. We are pleased to inform you that till date more than 3055 students & Pharma/Biotech/Life science professionals have taken the advantage of Raaj GPRAC workshops/seminars and courses organized in India. Candidates from Colombia, Iran, Singapore, UAE & US have also completed our courses in Regulatory Affairs. You will become Proficient in –
• Guidance on Regulatory Bodies like Indian CDSCO, DCGI, USFDA, EMEA, MHRA, TGA, MCC, MHLW & Row etc. Rules, Laws & Regulations of each country.
• Regulatory submissions in CTD/eCTD/ACTD/NeeS for Drug Product and DMF/ASMF for API
• Basic Understanding of ICH topics from Q1, Q2, Q3… to Q10, cGMP, GLP, GCP etc.
• Basics of CMC (Chemistry, Manufacturing & Control), International Document Standards, Technical Writing/Review Rules,
• Understanding of all Pharmaceutical Documentation required in the Industry (i.e. SOP, URS, Validation protocols/Reports, GMP documents, BMR/BPR, Specifications, Test Procedures, Mfg. procedures, Packaging specs, CTD all Modules, Clinical Protocols/Reports, Stability etc)
• Details of CTD modules I, II, III, IV & V and Understanding of eCTD modules, assisting in Compiling & filing of an eCTD Application. WE PROVIDE JOB ASSISTANCE AS WELL. You may speak to us for any clarifications.