Expertise & Services | GMP Compliance

Our Expertise & Services

A dedicated team of experts ensuring GMP compliance and Quality Systems excellence.

Our Expertise

Chaitali Prasad Vaidya

Miss. Chaitali Prasad Vaidya

Founder & Head – GMP Quality Systems

Qualification: M.Sc. Microbiology

Extensive experience in Pharmaceutical Quality Assurance and Quality Systems across Formulation and API units.

  • Microbiology laboratory advisory (Sterility, EM, ML testing documentation)
  • Formulation documentation review & process risk assessment
  • Compliance support for critical quality areas
Prasad Vijay Vaidya

Mr. Prasad Vijay Vaidya

Co-Founder | Director – Quality & Business Development

Qualification: M.Pharm | MBA (Marketing)

12+ years in Pharmaceutical Quality Systems and Quality Assurance.

  • Quality systems implementation & remediation advisory
  • GMP documentation & compliance strategy
  • Audit preparedness & client management
Amit Hatkhamkar

Mr. Amit Hatkhamkar

Head – Quality Control

Qualification: M.Sc.

10+ years in Pharmaceutical QC laboratories.

  • Analytical testing & stability studies
  • OOS/OOT investigation & RCA
  • QC data integrity, GMP & GLP compliance

Services

(Advisory & Supportive Only)

Global Regulatory Coverage: USFDA | WHO–Geneva | MHRA | ANVISA | TGA | ISO

Quality System & GMP Support

ISO Certification Support (9001, 14001, 45001)

Audit & Compliance Support

Validation & Qualification Advisory

Regulatory Support – Schedule M & Global GMP

Training & Capacity Building

Professional Consulting

Expanded Services

Facility & Area Qualification

Cleanroom classification, area qualification, layout and flow review for optimal compliance.

Layout & Process Compliance

GMP-compliant material & personnel flow advisory and comprehensive risk assessments.

Qualification & ValidationADVISORY

DQ/IQ/OQ/PQ documentation and review services to ensure system readiness.

Method Validation Support

Protocol and report review, including method transfer documentation for laboratories.

Utility System Validation

Advisory support for HVAC, water systems, compressed air, gases, and steam qualification.

Mock Audits & Preparedness

Gap analysis, CAPA planning, and comprehensive inspection readiness strategies.

QMS Support

Guidance on Change Control, Deviations, OOS, OOT, and Market Complaints management.

Risk Assessment (ICH Q9)

Structured risk management and reduction strategies based on global ICH Q9 standards.

Documentation Integrity

Advisory for Data Integrity compliance and ALCOA+ based documentation review.