We offered complete solution for DRAP related documentation. From new company registration to existing Company documentation, dossier formation and much more.

1. Product Registration & Licensing Services

A. Drugs / Pharmaceuticals

B. Biologicals

C. Medical Devices & IVDs

2. Establishment & Premises Licensing

• Manufacturer License (Drugs / Devices / Biologicals)
• Importer License
• Exporter Registration
• Wholesale / Distribution License
• Medical Device Establishment License (MDEL-style for DRAP)
• Warehouse & Storage approval support
• Pharmacist / Qualified Person appointment documentation

3. Quality Management & Compliance Services

• Development of DRAP-compliant SOPs
• Quality Management System (QMS) implementation
• GDP, GMP & ISO 13485 documentation
• Mock audits & internal compliance audits
• CAPA (Corrective & Preventive Action) management
• Vendor qualification & supplier audits
• Training programs for regulatory & QA staff

4. Import, Export & Customs Regulatory Support

• Import Permit / NOC processing
• Clearance documentation for DRAP-regulated products
• HS code & regulatory classification support
• Coordination with Customs, DRAP & Port Health
• Export registration & Free Sale Certificate (FSC)
• Controlled drugs & biological shipment approvals

5. Cosmetics & Nutraceuticals (if applicable)

• Cosmetic product enlistment / notification
• Ingredient compliance & labeling review
• Health supplements & nutraceutical registration
• Advertising & claims compliance review

6. Liaison & Representation Services

Regulatory hearing support

DRAP correspondence & follow-ups

Online DRAP portal submissions

Meeting representation with DRAP officials

Deficiency response preparation

B. Biologicals

C. Medical Devices & IVDs

Pharmaceutical HVAC Solutions

GMP-Compliant Environmental Control for Pharma Facilities

We deliver specialized HVAC solutions for the pharmaceutical industry, ensuring WHO-GMP, and DRAP compliance. Our systems protect product quality, ensure regulatory approval, and support uninterrupted manufacturing.

What We Do

Cleanroom HVAC Systems

• ISO Class 5–8 compliant designs
• HEPA / ULPA filtration
• Pressure cascade & airflow control
• Cross-contamination prevention

Temperature & Humidity Control

• Precise RH & temperature control
• Solutions for solid, liquid & sterile dosage forms

GMP HVAC Design & Consultancy

• Zoning & airflow planning
• New facility & retrofit solutions
• Risk-based GMP design approach

HVAC Validation & Testing

• DQ, IQ, OQ & PQ
• HEPA integrity testing
• Smoke studies & room mapping

Automation & Monitoring

• BMS & EMS integration
• Continuous data logging
• Audit-ready reports

Energy-Efficient Solutions

• High-efficiency AHUs & chillers
• VAV systems & energy recovery

Specialized Pharma Areas

• Sterile & aseptic areas
• Weighing & dispensing rooms
• QC laboratories
• Controlled warehouses & cold rooms

Why Choose Us

• Proven pharmaceutical HVAC expertise
• GMP-compliant designs & documentation
• Inspection-ready systems
• Energy-efficient & scalable solutions

Ready to Build a GMP-Compliant Facility?

From new pharmaceutical plants to HVAC upgrades, we deliver reliable, compliant, and efficient solutions.

Contact us today to discuss your pharmaceutical HVAC requirements.

We provide advanced dehumidification solutions engineered for HVAC systems and critical pharmaceutical environments where precise, very low humidity (≤ 25%) control is essential. Our systems are designed to meet the stringent requirements of cleanrooms, manufacturing areas, storage facilities, and laboratories, ensuring product integrity, regulatory compliance, and process reliability. With a focus on performance, efficiency, and validation-ready solutions, we support controlled environments that demand uncompromising humidity management.

One of our company segments specialized in delivering reliable storage and cold chain management solutions designed to preserve product quality, safety, and compliance across every stage of the supply chain. Our temperature-controlled facilities and monitoring systems support pharmaceuticals, healthcare products, and sensitive materials, ensuring consistent conditions, full traceability, and regulatory alignment. With a focus on precision, reliability, and risk mitigation, we help our clients protect the integrity of their products from storage to distribution.

Our team of experts not only work for in house but also deliver smart design solutions for cleanrooms and controlled airflow systems, engineered to meet the highest standards of contamination control and environmental precision to external clients. Our designs optimize airflow patterns, pressure differentials, and energy efficiency to support pharmaceutical, healthcare, and high-tech manufacturing environments. By combining engineering expertise with regulatory compliance, we create cleanroom solutions that ensure operational reliability, product protection, and long-term performance.

Training & Capacity Building

Training: Educate staff on proper gowning, handling, and preventing cross-contamination.

DRAP regulatory training workshops

GMP / GDP / ISO training

Pharmacovigilance & Materiovigilance training

Medical Device Rules 2017 & Amendments training

Customized corporate regulatory training programs