REG Solution is a full-service Regulatory Solutions and Services provider firm in Bangladesh.
We provide full-service Regulatory Solutions and Services and supporting Large, Medium and
Small size companies.

We have experience in Pharmaceutical (Human, Veterinary, Herbal) | Generics | Medical
Device | Biosimilar | Consumer Healthcare | Cosmetics in their entire Regulatory Strategy,
Intelligence, Dossiers, Submissions etc. We have also experience in Post- Approval/Legacy
Product Maintenance, Labeling, Artwork Change Management and other related functions.

REG Solution has a sound experienced registered Pharmacist, Engineers, Statisticians, and
Business Development team having 10 years experience in regulatory field.

Comprehensive Regulatory Solutions and Services

● Product Registration Holding/Authorized Representative
● Medical Device Registration
● Veterinary Medicine Registration
● Human Medicine Registration
● Project Profile & Licensing in Bangladesh
and Licensing in Bangladesh
● Regulatory Report Writing
● Import Pricing of Pharmaceutical Product
● Cosmetics & Consumer Goods Registration in Bangladesh
● Health Authority Interactions/Pre-submission Meeting
● Regulatory Intelligence Services
● Regulatory Compliance and Gap Analysis
● Labeling Compliance
      a) Pharmaceutical Product
      b) BSTI Products (Food/Cosmetic/Consumer)
● Literature Review Services
● Halal Certification
● Clinical Trail (Ethical Committee and Regulatory Authority Approval)
● Pharmaceutical Raw Material Source Validation/Registration

● Experienced Regulatory professionals to provide end-to-end Regulatory support from the
development stage to registrations and approvals for drugs and other products
● Expertise in handling pre-submission administrative activities
● Regulatory submission strategies for product rollouts and expansions to other regions
● Regulatory professionals with experience in compilation and submission
● Accurate scientific justifications for Health Authority/Regulatory Body query responses

● Regulatory Planning
● Document Submission Management and Tracking
● Regulatory Content/Information Management
● Regulatory Change Control Management
● Label/Art Work/Packaging Checking
● Integrated Regulatory Information
● Regulatory Intelligence
● Regulatory Reporting and Analytics