Regulations | Expertise | Guidance
SERVICES
1. Product Registration Holding Service
We provide registration holding service for your Pharmaceutical Products like Human Medicine, Veterinary Medicine Medical Devices or Active Pharmaceutical Ingredient (API). REG Solution can act as local agent and distributor in Bangladesh for any foreign manufacturer. REG Solution has the following updated legal documentation to act as local agent/distributor for Bangladesh market:
- Trade license
- TIN certificate
- Current Bank account
- VAT registration certificate (BIN)
- Import registration certificate (IRC)
2. Medical Device Registration in Bangladesh
We are regulatory solutions and services provider in Bangladesh.We have experience in pharmaceuticals regulatory frame work in Bangladesh. We are expert in medical device dossier evaluation, Gap analysis, registration and approval in Bangladesh. We are providing medical device classification (A, B, C & D) service and check list for registration as per Medical Device Guideline in Bangladesh. REG Solution as regulatory service provider can provide end-to-end Regulatory affairs services to medical device products manufacturers and importers
3. Veterinary Medicine Registration in Bangladesh
Veterinary Medicine has to be registered by DGDA, Bangladesh forthe regulation and approval for import and manufacture. REG Solution is highly experienced veterinary medicine registration service provider in Bangladesh. We are providing veterinary medicine registration service, DCC checking and import check list for registration as per law in Bangladesh. REG Solution as regulatory service provider can provide end-to-end Regulatory affairs solutions and services to veterinary products manufacturers and importers.
4. Human Medicine Registration in Bangladesh
Human Medicine has to be registered by DGDA, Bangladesh for the regulation and approval for import and manufacture. REG Solution is highly experienced Human medicine registration service provider in Bangladesh. We are providing Human medicine registration service, DCC checking and import check list for registration as per law in Bangladesh. REG Solution as a regulatory service provider can provide end-to-end Regulatory affairs solutions and services to human medicine manufacturers and importers.
5. Project Profile & Licensing in Bangladesh
Before manufacturing any drug (Pharmaceutical/Medical Device/API/Veterinary/Herbal/Ayurvedic) in Bangladesh 1st you have take project profile approval from DGDA. After project profile approval you can submit for application for manufacturing. So project profile approval is very important for any manufacturer in Bangladesh. Bangladesh Regulatory requirements are very dynamic and becoming stringent respect to the development, manufacturing and distribution. REG Solution has a sound experienced Pharmacist and Engineering team to assists organizations with specialized project profile services to overcome the challenge of drug manufacturing license
6. Import Pricing of Pharmaceutical Product
Imported pharmaceutical product price is 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 price. But if you can estimate the product’s MRP before import you can set a marketing plant and budget. REG Solution as a regulatory service provider can provide end-to-end import product pricing solutions for importers.
7. Cosmetics & Consumer Goods Registration in Bangladesh
BSTI Brought 227 Products under Mandatory Certification Marks Wing. Cosmetics and consumer goods have to be registered by BSTI, Bangladesh for the regulation and approval for importer and manufacture. We are providing BSTI services like composition/formulation checking as per Bangladesh Standard (BDS) for importer and manufacturer.
8. Health Authority Interactions/Pre-submission Meetings
Appropriate and timely communication with Health Authorities (HAs) is a key factor for successful and speedy approvals and uninterrupted commercialization of a medicinal product. Health Authority interactions and Pre-submission meetings are very crucial as they give the opportunity to the applicant to interact with HAs to understand the HA requirements/opinion in detail on a proposed Regulatory submission and to explain the applicant’s rational/ strategy for respective Regulatory affairs submission. With a strong footprint in handling Health Authority Interactions and Agency meetings for different stages of development and with various health authorities, REG Solution is proven to be a preferred Regulatory partner.
9. Regulatory Intelligence Services
Bangladesh Regulatory requirements are very dynamic and becoming stringent with respect to the development, manufacturing and distribution of pharmaceutical others products. Given the dynamic nature of regulations manufacturers and importers are facing challenges in decoding and understanding updated Regulatory compliance requirements. We are providing Regulatory Intelligence Services of below sector.
DGDA
- Pharmaceutical Product
- Veterinary Product
- Medical Device
- Herbal/Neutraceutical Product
- Active Pharmaceutical Product (API)
- No Objection Certificate (NoC)
BSTI
- CM License
- Release Letter for Imported Products
- Chemical/Physical Testing Service
- Bangladesh Standard (BDS)
10. Regulatory Compliance and Gap Analysis
Regulatory Assessment/Gap analysis of the supporting documents/data is very critical for the registration of medicinal products. Though most of the Health Authorities (HAs) accept applications/dossiers in the CTD format. Bangladesh Health Authority also accept CTD format for Import Registration but need to submit different legal documents for registration. Thus, a thorough gap analysis/technical assessment of the documents/data enables the manufacturers/importers to identify and mitigate the gaps before Regulatory submission. It will avoid Regulatory rejections of the submissions and minimize the major/critical queries to fasten the approvals. Gap analysis of the legacy dossiers against current practices followed for the manufacture of the medicinal products will ensure the Regulatory compliance of the product. The identified gaps can be mitigated by the submission of the probable supplements/variations to avoid the non-compliant Regulatory practices. REG Solution as a Regulatory service provider with the experienced Regulatory affairs resources provides gap analysis support.
11. Labeling Compliance
a) Pharmaceutical Product : Labeling is an interdisciplinary function that serves as the basis on which prescribing information, advertising and promotional materials for the medication are henceforth created. Pharmaceutical product labeling is a complex process which involves multiple rules, regulation in Bangladesh. Proper labeling information, to effectively maintain the safety and efficacy of a drug, is essential for pharmaceutical companies.
b) BSTI Products (Food/Cosmetic/Consumer) : With modern society becoming increasingly focused on healthy eating and life style. Food/Cosmetic/Consumer products labeling helps the consumer to make an informed decision. In its simplest form, a label communicates the existing product information to the customer, thus assisting him in understanding the key ingredient, nutritional and safety information he needs to know about the product. Be it the initial product specification, the pack copy or the final artwork approval. Labeling or development of product label is a complex and challenging process. An effective and robust labeling system should ideally include a defined process, tracking tools and well-trained labeling professionals. REG Solution has experience in Core Patient Information Leaflet (Core PIL) and existing labeling setups to ensure labeling compliance as per different Bangladesh rules.
12. Literature Review Services
Medical literature is an important source of information on suspected adverse reaction case reports. As regulations are becoming more stringent, marketing authorization holders (MAHs) may face the challenge of incorporating ever-increasing safety data from literature into their pharmacovigilance (PV) efforts to achieve compliance. The quality and efficiency of the literature monitoring process has a significant impact on the quality of periodic safety reports, detection of new safety signals and eventually benefit-risk evaluation (BRE) of medicinal products. REG Solution has a good Doctors team to assists organizations with specialized literature compliance services to overcome the challenge of monitoring literature.
13. Halal Certification
Halal certification is a process which ensures the features and quality of the products according to the rules established by the Islamic Council that allow the use of the mark Halal. It is mainly applied to meat products and other food products such as milk, canned food and additives as well as Pharmaceutical/ Neutraceutical/Herbal product. REG Solution is highly experienced HALAL Certificate service provider in Bangladesh. We are providing HALAL Certificate registration service as per law in Bangladesh. REG Solution as a regulatory service provider can provide end-to-end Regulatory affairs solutions and services to HALAL products manufacturers and importers