Regulatory Affairs

Regulatory Affairs

We provide services for designing & commissioning of old and new manufacturing facilities complying national and international c-GMP / FDA guidelines with separate man material floor, no scope for cross contamination separate raw material and FG floor and clean room as per ISO8 guidelines for followings;

1. Nutraceutical / Food Products manufacturing facilities
2. Pharmaceutical Formulations/ Drug Products Manufacturing Facility (Tablets , Capsules , Liquid Orals , Injections & Ointments)
3. Cosmetic , Herbal & Ayurvedic Product manufacturing facilities
4. Medical Devices Manufacturing facilities
5. API manufacturing facilities ( Sterile & non Sterile)
6. Key starting Material and intermediate Manufacturing facilities

• Designing of NEW Manufacturing Facilities (Green Field Project) meeting US-FDA, EU-GMP, PIC/c and WHO guidelines
• Designing of OLD Manufacturing Facilities (Brown Field Project) meeting US-FDA, EU-GMP, PIC/c and WHO guidelines