GMP Consulting



GMP Auditing

  • Conduct mock audits of clients' site to determine readiness for FDA inspection
  • Due diligence audits
  • Third party audits on behalf of procurement companies
  • GAP assessment audit

GMP Training

  • We can develop and deliver a comprehensive and meaningful in-house training program that is tailored to, and appropriate for, client's specific needs.
  • In-house training is the most cost-effective means to improve the skills and capabilities of the employees.
  • It is helpful because of convenience and less disruption, value for the money, save time, provide freedom of expression and maintain confidentiality, provides freedom to discuss client's own case studies, better interaction and effective learning.


  • Review of microbial testing methods/ procedures viz., Growth promotion testing, Microbial limit testing, Sterility testing, antimicrobial & preservative effectiveness, Bacterial endotoxins testing, Water testing etc.
  • Development of Environmental Monitoring (EM) program.
  • Development of contamination control program.
  • Development of microbiology method validations protocol.
  • Development of admixture studies.

Setting-up Facility

  • Setting up Quality control and Quality assurance department.
  • Setting up Microbiology laboratory
  • Settling up Injectable facility.
  • Review of layout of finished dosage manufacturing facility.
  • Setting up cleanroom laundry facility of a multinational company in India.
  • Setting up world class desiccant manufacturing facility.
  • Review of validation protocols and reports.
  • Reviewing company practices and providing advice on changes to systems in line with regulatory expectations.
  • Development of Quality Management Systems (QMS)/Pharmaceutical Quality Systems (PQS).

Aseptic Processing

  • Provide support in development of Aseptic Process Simulation.
  • Equipment procurement
  • Qualification of equipment
  • Qualification of facility
  • Qualification of utilities
  • Process validations (Terminal Sterilization and Aseptic Processing)

Regulatory Services

  • Review of Abbreviated New Drug Application (ANDA) submissions.
  • Review of Drug Master File (DMF) submissions.
  • Guidance for preparation of ANDA and DMFs.
  • Support in preparation of Remedial Action Plan (RAP) post FDA inspection.
  • Provide support in drafting response to regulatory audit observations.

Services Provided

Currently we offers services to following industries:

  • Pharmaceutical finished dosage
  • Active pharmaceutical ingredients
  • Drug excipients
  • Medical devices