To manufacture human and veterinary drugs in Pakistan, an authorization from DRAP in the form of a Drug Manufacturing License (DML) is require. Professional Experts in our Domain of Licensing assist the clients in selection of manufacturing site, developing a layout plan, and completing the online application process for Drug Manufacturing License.
The process of Grant of Drug Manufacturing License (DML) is a 3 steps procedure;
The application for grant of DML is made on form-1 with all required documents by pharmaceutical company on the DRAP e-Services Portal, while the renewal application of DML is made on form-1A. The overall process of DML is divide into 3 steps which are mentioned below:
Step I: Verification of Proposed Manufacturing Site
Step II: Approval of Layout plan of Proposed Site
Step III: Grant of Drug Manufacturing License (DML)
Professional Experts in our Domain of Licensing assist the clients in each step of DML process by providing assistance in selection of manufacturing site, developing a layout plan, and applying the online application process for Drug Manufacturing License.
Basic Requirements:
- Manufacturer Business is a registered company as per SECP Regulations.
- Minimum Area Requirement for Pharmaceutical unit is Not Less Than 2000 Square Yards.
- HVAC system is Mandatory.
- Quality Control Department is also Mandatory
How Fast Regulatory Consultancy Firm expedites Licensing processes efficiently:
Expert Guidance Available: Professional expert guidance for Form-1 & Form-1A online Application submission.
Advisory on pharma regulations: Expert guidance on DRAP Rules & regulations about DML Process.
Customized approach: Customized Services for Company & product registration in pharmaceutical field.
Improved Business development: Accelerate Licensing approval process through Govt. bodies & bring drugs to the market.