Regulations | Expertise | Guidance
INFORMATION SERVICE
1. Medicine Import Data
Human or Veterinary Medicine controlled by DGDA (Local FDA), Bangladesh as per law. Regulatory process and requirements are very stringent in Bangladesh. Given the nature of regulations, importers are facing challenges in decoding and understanding import. But if you can estimate the product’s MRP/Import Data, Principle/Manufacturer actual price etc. before import you can set a marketing plant and budget. REG Solution as a regulatory service provider can provide end-to-end Medical Device Import Data solutions for importers and Manufacturers with a minimal service fee.
2. Medical Device Import data
Medical devices are being controlled and regulated by DGDA (Local FDA), Bangladesh as per law. Regulatory process and requirements are very stringent in Bangladesh. Given the nature of regulations, importers are facing challenges in decoding and understanding import. But if you can estimate the product’s MRP/Import Data, Principle/Manufacturer actual price etc. before import you can set a marketing plant and budget. REG Solution as a regulatory service provider can provide end-to-end Medical Device Import Data solutions for importers and Manufacturers with a minimal service fee.
3. DCC
All drugs that are produced in different dosage forms, imported, distributed or marketed or used have to be registered by licensing authority based on the recommendation of Drug Control Committee (DCC) as per law.
DCC submission rules regulation and the process is important part of DCC approval. Before submission of any dossier in Bangladesh National Regulatory Authority of drug you have to check either the drug is approved by DCC or not. REG Solution has a sound experienced regulatory expert team to assists your DCC approval status checking service with a minimal service fee.
Different Decision of DCC
If you have a good experience in different decision of DCC, your regulatory submission and the pathway will be smooth to get any approval. REG Solution will be your trusted partner to know the different decision of DCC from our experienced regulatory expert team. We can assist your team to know the different DCC decision with a minimal service fee.
4. Guidance Documents
Do you know National regulatory Authority (DGDA) adopted different WHO TRS and Guidance?
REG Solution will be your trusted partner to know the different adopted Guidance Documents and SOP like Post Marketing Variation, Advertisement Guideline, Marketing Authorization SOP etc. We can assist your RA/QA/QC/PD and Marketing team to know the different Guidance Documents and SOP with a minimal service fee.
5. API Source and Price
Bangladesh Regulatory requirements are very dynamic and becoming stringent. Dynamic nature of regulations manufacturers and importers are facing challenges in decoding and understanding updated Regulatory compliance requirements. Before starting your product development or purchasing raw material, API Source and Price verification is very necessary for Pharmaceutical Business. We are providing API Source and Price service with a minimal service fee.
6. Project Profile Information
Before manufacturing any drug (Pharmaceutical/Medical Device/API / Veterinary / Herbal / Ayurvedic) in Bangladesh 1st you have to take project profile approval from DGDA. Break even analysis, Sales forecast are most significant part in project profile. REG Solution has a sound experienced Pharmacist, Engineers, Statisticians, Sales and Marketing team to assists your Break even analysis, Sales forecast service with a minimal service fee.