Here are the main activities we performs with the DGDA:

🗂️ 1. Drug/Medical Product Registration & Licensing

• Assist in the registration of pharmaceutical products, biologics, vaccines, medical devices, and cosmetics.
  
  

• Prepare and submit dossiers as per DGDA requirements (in CTD/eCTD format, if applicable).
  
  

• Help obtain:
  
  

  • Drug manufacturing licenses
    
    

  • Import registration
    
    

  • Export NOC
    
    

  • Product marketing authorization (MA)
    
    

• Support in registering API (Active Pharmaceutical Ingredient) and excipients.
  
  

🧪 2. Clinical Trial & Bioequivalence (BE) Application Support

• Guide on application procedures for clinical trials and bioequivalence studies in Bangladesh.
  
  

• Assist in preparing documents for Ethics Committee and DGDA clearance.
  
  

• Coordinate between CROs, manufacturers, and regulatory bodies.
  
  

📑 3. Regulatory Documentation & Dossier Preparation

• Compile and review Common Technical Documents (CTD), including:
  
  

  • Module 1 (Administrative)
    
    

  • Module 2–5 (Quality, Safety, and Efficacy)
    
    

• Ensure proper formatting and compliance with DGDA Act and Rules.
  
  

• Provide translation and legal document preparation where needed.
  
  

🌐 4. Import, Export & NOC Clearance

• Assist in obtaining:
  
  

  • Import Registration Certificates
    
    

  • Import Permission/NOC
    
    

  • Export NOC or Free Sale Certificate (FSC)
    
    

• Help with controlled drug import/export documentation (e.g., psychotropics, narcotics).
  
  

• Guide on HS codes, customs clearance regulations, and DGDA requirements at ports.
  
  

🏭 5. GMP Compliance & Audit Preparation

• Support companies in aligning with cGMP (current Good Manufacturing Practice) guidelines.
  
  

• Assist in preparing for GMP inspections by DGDA or WHO prequalification.
  
  

• Conduct mock audits, gap analysis, and provide SOP writing support.
  
  

🧾 6. Renewal, Variation & Post-Approval Activities

• Manage renewals of drug licenses, registrations, and import permissions.
  
  

• Help file post-approval changes (variations): packaging, site change, composition update, etc.
  
  

• Respond to regulatory queries or deficiency letters from DGDA.
  
  

🧴 7. Cosmetics & Medical Device Compliance

• Register and obtain import approval for cosmetic products and medical devices.
  
  

• Classify products as per DGDA guidelines and advise on applicable regulatory paths.
  
  

📚 8. Training & Regulatory Updates

• Provide training for company staff on:
  
  

  • DGDA guidelines
    
    

  • Pharmacovigilance requirements
    
    

  • Product labelling and packaging compliance
    
    

• Disseminate regulatory updates, alerts, and circulars issued by DGDA.
  
  

📬 9. Liaison & Representation Services

• Act as a local agent or authorized representative for foreign companies.
  
  

• Liaise with DGDA officers and technical committees for application follow-ups or technical clarifications.
  
  

💊 10. Pharmacovigilance & Post-Marketing Surveillance Support

• Guide on Pharmacovigilance (PV) system set-up and reporting adverse drug reactions (ADR).
  
  

• Assist in preparing PSURs (Periodic Safety Update Reports) and risk management plans as per DGDA requirements.

Main activities such we performs in  DNC:

⚖️ 1. Narcotics, Psychotropics & Precursor Licensing

• Assist in obtaining:
  
  

  • Narcotic Drug Handling Licenses
    
    

  • Precursor Chemical Licenses
    
    

  • Psychotropic Substance Licenses
    
    

• Help determine which license is required based on product classification under national drug laws and UN conventions.
  
  

🛃 2. Import/Export Permit Facilitation

• Support clients in acquiring Import Permits for controlled substances (e.g., narcotics, ketamine, ephedrine).
  
  

• Assist in getting Export Permits and No Objection Certificates (NOC) for international shipments.
  
  

• Coordinate with DNC and Customs to ensure clearance of regulated substances.
  
  

📑 3. Application & Documentation Support

• Prepare and submit all required documents for:
  
  

  • License applications
    
    

  • Permit renewals
    
    

  • Quota allotments
    
    

• Ensure completeness of:
  
  

  • Company profile
    
    

  • Usage declaration
    
    

  • Security measures
    
    

  • Storage documentation
    
    

🧪 4. Usage Justification & Quota Allotment

• Assist companies in applying for annual quotas for narcotics or precursors based on:
  
  

  • Production requirements
    
    

  • R&D usage
    
    

  • Medical need
    
    

• Help justify the quantity required and ensure adherence to DNC's annual quota regulations.
  
  

🏭 5. Storage, Transport & Handling Compliance

• Guide clients in maintaining proper storage conditions, physical security, and record-keeping protocols.
  
  

• Assist with compliance on:
  
  

  • Transport documentation
    
    

  • Inventory registers
    
    

  • Loss/theft reporting
    
    

📋 6. Site Inspection & Audit Preparation

• Prepare clients for DNC inspections for:
  
  

  • New license approval
    
    

  • License renewal
    
    

  • Compliance audits
    
    

• Conduct mock inspections, gap analysis, and compliance training.
  
  

📊 7. Recordkeeping & Reporting Systems

• Help implement logbooks, usage registers, and inventory tracking systems.
  
  

• Assist in preparing and submitting monthly, quarterly, or annual reports to DNC as required.
  
  

🌐 8. Regulatory Updates & Advisory

• Provide regular updates on changes in:
  
  

  • DNC guidelines
    
    

  • UN/INCB regulations
    
    

  • Government circulars on narcotics control
    
    

• Advise on classifying new products as controlled or exempted substances.
  
  

🧾 9. License Renewal & Compliance Support

• Track and manage license validity, renewals, and amendments (e.g., location, product scope).
  
  

• Help respond to notices or show-cause letters issued by DNC.
  
  

💼 10. Liaison with DNC Officials

• Represent clients in official dealings with DNC authorities.
  
  

• Follow up on pending applications, inspection scheduling, and permit approvals.

Here are the main activities such a we perform:

🔍 1. Product Certification Support

• Assist in obtaining BSTI Certification Marks (CM Licence) for both local and imported products.
  
  

• Guide on mandatory and voluntary certification requirements under BSTI regulations.
  
  

• Support in preparing and submitting applications, including:
  
  

  • Test reports
    
    

  • Technical documents
    
    

  • Declarations
    
    

  • Sample preparation
    
    

📑 Regulatory Compliance Advisory

• Explain BSTI Acts, rules, and regulations relevant to the client’s products.
  
  

• Interpret latest updates in BSTI requirements (e.g., changes in standards or enforcement).
  
  

• Help ensure that packaging, labeling, and claims comply with Bangladesh Standards.
  
  

🧪 Testing & Standardization Guidance

• Help companies prepare for product testing by BSTI-approved laboratories.
  
  

• Recommend product design or formulation changes to meet BSTI standards.
  
  

• Coordinate pre-compliance testing (before formal submission to BSTI).
  
  

📂 Documentation & Application Management

• Draft and compile all necessary technical documentation for BSTI submissions.
  
  

• Support importers in obtaining CM license or clearance from BSTI.
  
  

• Maintain liaison with BSTI officers to track application progress.
  
  

🌐 Import Clearance & Customs Compliance

• Provide guidance for importers needing BSTI clearance before customs release.
  
  

• Assist in getting No Objection Certificates (NOC) or test exemptions when applicable.
  
  

• Help navigate the BSTI clearance process for items under mandatory certification.
  
  

🏭 Factory Inspection Preparation

• Help domestic and foreign manufacturers prepare for BSTI factory audits.
  
  

• Support implementation of Quality Management Systems (QMS) required by BSTI.
  
  

• Conduct mock audits or gap analysis before official BSTI inspections.
  
  

📘 Training & Awareness Programs

• Provide training to employees on regulatory and quality compliance.
  
  

• Offer workshops on BSTI standards, product safety, labeling laws, etc.
  
  

🧾 License Renewal & Post-Certification Compliance

• Remind clients of upcoming renewal deadlines.
  
  

• Assist with periodic surveillance audit readiness.
  
  

• Help address non-compliance notices or appeals.

The main activities such we perform at DLS:

🔹 1. Regulatory Affairs & Product Registration

1. Preparing and submitting dossiers for the registration of Veterinary drugs (antibiotics, anthelmintic, etc.) Vaccines and biologicals, Feed additives and nutritional supplements

2. Liaising with the DLS Drug Control Section and Livestock Directorate to track application status and respond to queries.

3. Ensuring products comply with Bangladesh's Drug Act and veterinary-specific regulations.

🔹 2. Regulatory Strategy & Compliance Advisory

1. Advising clients (importers, local manufacturers, MNCs) on Changes in DLS regulations, Labelling, packaging, and advertising requirements, Withdrawal periods, residue limits, and banned substances

2. Helping ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.

🔹 3. Import Licensing & Customs Clearance Support

1. Assisting clients in obtaining Import permits, NOC (No Objection Certificate) from DLS, Customs documentation review

2. Facilitating coordination between DLS and other authorities like DGDA, BSTI, or Customs Department.