- API company
- Foreign company need Local regulatory support
- CRO industry
- BE study Monitors
- Any regulatory service in DGDA including local representative, filling, registration, renewal, variation, PV, Medical device, etc.
Local Technical Representative (LTR)
- Local responsible company on behalf of Foreign company for all regulatory functions (Local Partner)
- All DGDA activities and registrations
- Import license
- API source validation
- Medical device registration
- Veterinary product registration
- Biosimilar & Vaccine registration
- Pharma project submission & consultancy
- ICSR submission & All PV responsibilities
- Packaging compliance/Labeling compliance service
- Managing Variations
- Local Translations of document
- Connecting with local distributors / CMO / CDMO / Pharma companies etc
Business Plan
- Idea / concept for new market
- Market Research / intelligence report
- Business Plan report, Marketing Plan report
- Project Management for business launch
- Training – Sales / Marketing team
International Regulatory
- Training on CTD / ACTD / eCTD
- Compilation, gap analysis, making submission ready for any CTD
- Consultancy service based on specific product for specific target market (Regulatory Pathway)
- Project Management for R&D development
- Connecting to other vendors or service providers
Clinical trial
- Protocol, ICF, CRF, Study result writing (medical writing)
- SOP preparation for Clinical trial outsourcing
- Selecting CRO / Site / PI based on product & budget
- Clinical trial / BE study Monitoring
- BE study Outsourcing
- Training of Clinical Development Personnel
- Training on GCP
- Project Management for Post Marketing study of Biosimilar or vaccine
Pharmacovigilance
- Training on Pharmacovigilance
- RMP, PSUR report writing
- SOP preparation for Pharmacovigilance
- Pharmacovigilance set up for a company
- Pharmacovigilance responsibility outsource (PV CRO) – QPPV service
Medical Device Services
- Clinical Evaluation Plan (CEP) writing
- Preparation of Technical Document, Essential requirement part writing
- Bio-compatibility study outsourcing
- Selecting Notified Bodies, EU Authorize Representatives
- ISO 13485 & CE Marking preparedness
Intellectual Property Rights (IPR)
- New Trade Mark, Patent submission management
- Training on IPR & Data protection
- Training on Patent search
- Patent Search for specific molecule or product
- Patent litigation advice
Active Pharmaceutical Ingredients (API)
- Selection of API, Business plan
- Lowest cost synthetic route for API
- Training of DMF, ASMF, CEP etc
Talent Hunt
- Bangladesh
- India
- Sri Lanka
Other
- Any Training as per customer requirement
- Any Event Management
- Anyone need a platform