Pharma Manufacturers in India

Pharmaceutical Regulations

1. Pharmaceutical Regulatory Affairs and Compliance

At Neiss Labs we are constantly improving our quality standards in all areas and we understand the need to anticipate and be prepared for stricter Regulatory requirements in the countries that we are exporting to as well as in our home country. At Neiss Labs the Regulatory Department works closely with the Production and Quality departments to ensure that the high standards being followed are captured in documentation. We understand that from the Point of view of the Regulatory Agencies WHAT IS NOT DOCUMENTED, HAS NOT BEEN DONE. Our pharma manufacturing plants are WHO-GMP compliant. The manufacturing facilities are in compliance with major regulatory bodies around the world including MCA, TGA and MCC.

2. Regulatory Affairs in Pharma Industry: Support & Services

Besides documents such as raw material, finished product and packaging specifications, method of analysis, certificate of analysis, validation of method of analysis, validation of manufacturing process, in-process controls etc, we can also provide

  • Clinical Trials
  • FDA certificates
  • BE studies

for registration of our products as per guidelines of health authorities in most countries.

Pharma Compliance

The Quality Control Department has experienced and competent and technically qualified personnel to shoulder various activities of the department. The head of quality control has sufficient experience in the quality control functions as applicable to pharmaceutical formulations.


Quality control

Quality control is responsible for sampling and analysis as per approved specifications. Release/ reject authority for all raw materials, packing materials, intermediate products and finished products lies with quality control only, but final release authority for product lies with Quality Assurance.

Neiss Labs is in tune with the current manufacturing trends in healthcare industry. Our manufacturing plants are WHO-GMP compliant. The manufacturing facilities are in compliance with major regulatory bodies around the world including MCA, TGA and MCC. Being in the business of healthcare products, Neiss Labs acknowledges quality as the first and the foremost important aspect. The key ingredients of manufacturing process clearly indicate the Neiss Labs’ commitment towards quality, they are…

  • Exhaustive Specifications for Inputs & Outputs
  • Validated Manufacturing Methods
  • Stringent In-process Controls
  • Validated Batch Manufacturing Procedures
  • Validated & Approved Analytical Procedures
  • Independent Quality Assurance Department
  • Elaborate Standard Operating Procedures

Quality Control department and the Quality Assurance Department ensures that each aspect of the plant, product and processes being followed have quality built into them.

Regulatory department adept at providing complete documentation like regulatory dossiers

Quality-Assured Pharmaceutical Products

Pharmaceutical Amenities

Demineralization Plant and pipeline in loop form with a 5 micron filter and UV lamp for absolute purity of water.

Multicolumn Distilled water plant with storage & Distribution at through lines in closed loop. Still room with class D conditions

Well equipped Quality Control Laboratory with modular furniture including H.P.L.C.

Microbiology & Sterility area under class 10,000

Raw Materials

Dispensing of materials under reverse laminar flow.

Ample segregated storage for raw materials and packaging materials, with a quarantine facility

Separate air handling units for every production departments, in addition to air conditioning with 3 micron filtration to ensure absolute product purity

Air Handling Units (AHU)

Individual compression and coating cabins with separate air handling units to avoid cross contamination.

Separate double skin Air Handling Units for vial/ampoule washing, sterilization, buffer zone and airlocks, filling areas confirming to class D, C, & B.

Separate Air Handling Units for powder filling area


State of art vial / plastic dropper filling / sealing line for untouched operation

Visual inspection of ampoules with semi automatic inspection of machines

Extensive training and retraining of personnel to ensure they stay current with latest technological developments

Alternative power generation system for uninterrupted production

Unidirectional flow of men and materials to promote optimum productivity

Accessibility of all utilities and maintenance areas from outside, for additional ease of operation