Services

GMP & Regulatory Consultancy

We provide comprehensive GMP and regulatory consultancy support to help organizations establish, upgrade, and sustain compliant systems. Our services include interpretation of regulatory requirements, gap analysis, and structured implementation plans aligned with applicable guidelines.

Key areas include:

cGMP implementation and system strengthening
Revised Schedule M compliance support
Facility and documentation gap analysis
Regulatory inspection preparedness

Quality Assurance Support

Our Quality Assurance services focus on developing robust Quality Management Systems that support consistent product quality and regulatory compliance.

Support areas include:

SOP development, review, and harmonization
Deviation, CAPA, and change management systems
Documentation practices and record management
QMS strengthening and system integration

Quality Control & Analytical Support

We provide guidance for establishing and maintaining compliant laboratory systems in line with regulatory expectations.

Support includes:

QC laboratory setup and workflow optimization
Analytical method validation guidance
Stability study systems (ICH Q1)
Data integrity awareness and best practices

Regulatory Affairs Support

We assist organizations in preparing and reviewing regulatory documentation and responding to regulatory observations with clarity and accuracy.

Services include:

Technical document review
Regulatory query response support
Dossier preparation assistance
Inspection response strategy

Training & Capability Development

We conduct structured training programs aimed at strengthening technical knowledge and compliance awareness across all levels of the organization.

Training areas include:

GMP awareness programs
QA & QC technical training
Revised Schedule M focused sessions
Customized corporate training modules

Turnkey Project Management & Compliance Integration

PharmaHealth Insights provides structured turnkey project management support with strong regulatory and quality integration, ensuring that projects are executed with compliance built into every stage.

Our role focuses on coordinating multiple stakeholders, aligning engineering execution with regulatory expectations, and ensuring smooth transition from concept to commissioning.

Scope of support includes:

Concept development and feasibility assessment
Facility layout planning and process flow design
User Requirement Specification (URS) preparation
Vendor identification, technical evaluation, and coordination
Project execution monitoring and milestone tracking
Utility and cleanroom coordination
Qualification, validation, and documentation support
Regulatory compliance readiness at completion stage

Through a collaborative execution model, we ensure that technical implementation, quality systems, and regulatory compliance progress in parallel, minimizing rework, delays, and inspection risks.