Time Consultancy

Export

* Pharmaceutical product export.

* Cosmetic product export.

* Supplement product export.

* Herbal product export.

* Probiotic product export.

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*  USFDA, MHRA, TGA, GCC etc. approved manufacturing facility for pharmaceutical, cosmetic, supplement and food products. 

Third Party Manufacturing

* All Pharmaceutical, supplement and cosmetic products third party manufacturing.

* All Therapeutic class and all dosage forms like tablet, capsule, liquid, PFS, injection, cream, ointment, soft gel capsule manufacturing.

*  USFDA, EU, TGA etc Approved manufacturing facility.

*  Cost effective manufacturing.

*  One stop solution for third party manufacturing.

FACILITY DEVELOPMENT

*  Turnkey manufacturing facility development.

*  Biotech product manufacturing factory setup including insulin, vaccine.

*  Cosmetic product manufacturing facility setup.

*  Supplement product manufacturing factory setup.

*  Herbal product manufacturing factory setup.

TECHNOLOGY TRANSFER

* All types of formulation development and Technology transfer for commercial production.

* Biotech product like insulin, antiviral and anticancer tech transfer.

* Technology transfer to the production after successful product development. 

* Different dosage forms manufacturing like tablet, capsule, powder for suspension, * * ointment, Kidney Dialysis Fluid, Injection

* Manufacturing problem solution. Process Validation.

API AND BULK DRUG SUPPLY & MANUFACTURING FACILITY SETUP

1. BOD PREPARATION

2. PROJECT PROPOSAL AND BUSINESS PLANING

3. IDEA GENERATION

4. PRELIMINARY DESIGN DEVELOPMENT​

• Master plot plan

• Production Layout/ Design

• Material Handling Philosophy 

• Process Flow Diagrams (PFD)

• Space Qualification

• Facility Flow Diagrams (FFD)

• HVAC (Heat,  Ventilation  and  Air  Conditioning)

Regulatory Submission of Pharmaceutical Products, APIs, Medical devices

Our consultancy offers comprehensive regulatory support tailored to the submission needs of pharmaceutical products in Bangladesh. We specialize in guiding clients through the complex regulatory landscape, ensuring compliance with the stringent requirements set forth by the Directorate General of Drug Administration (DGDA).

• Services Offered:

1. Active Pharmaceutical Ingredients (APIs) Submission: We provide end-to-end support for the regulatory submission of APIs, including dossier preparation, compilation, and submission to the DGDA. Our experts ensure that all documentation meets the regulatory standards, covering aspects such as quality, safety, and efficacy of the API.

2. Finished Pharmaceutical Products (FPPs) Submission: Our consultancy assists in the preparation and submission of regulatory dossiers for finished pharmaceutical products. From formulation development to stability studies, we offer guidance at every stage to ensure compliance with Bangladesh's regulatory requirements.

3. Medical Devices and Surgical Items: We offer specialized expertise in navigating the regulatory framework for medical devices and surgical items. Our services include classification, registration, and documentation preparation, ensuring smooth approval processes with the DGDA.

• Why Choose Us:

1. Expertise: Our team comprises regulatory experts with extensive experience in the pharmaceutical industry and in-depth knowledge of Bangladesh's regulatory requirements.

2. Customized Solutions: We offer personalized consultancy services tailored to the unique needs of each client, ensuring efficient and cost-effective regulatory compliance.

3. Timely Support: We prioritize promptness and efficiency in delivering regulatory solutions, helping clients navigate the submission process with minimal delays.

4. Comprehensive Guidance: From initial strategy development to final approval, we provide comprehensive support at every stage of the regulatory journey.