FDA & GMP Regulatory Compliance
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GMP Auditing

GMP Auditing

Ensuring your facility is inspection-ready is a critical step toward regulatory success. Our comprehensive GMP auditing services are designed to assess, identify, and resolve gaps in compliance with international standards, including those set by the US FDA, WHO, EU, and other global regulatory authorities.

Our GMP Auditing Services Include:

  • Mock Regulatory Audits : Simulate FDA and other international inspections to evaluate your site’s compliance status and readiness. We provide detailed audit reports with actionable recommendations.

  • Due Diligence Audits : Perform thorough evaluations of potential partners, contract manufacturers (CMOs), or suppliers to support strategic decisions during mergers, acquisitions, or partnerships.

  • GAP Assessment Audits : Identify deviations from cGMP requirements by benchmarking your quality systems against current industry standards and best practices. Our GAP analysis helps develop a roadmap for full compliance.

  • Third-Party Audits : Conduct independent audits on behalf of pharmaceutical procurement agencies or global companies to ensure supplier compliance and product integrity.

  • Pre-Audit Preparation and Support : Assist in preparing documentation, training personnel, and organizing systems before an actual inspection by regulatory bodies.

  • Post-Audit Remediation Support : Offer guidance in addressing audit findings, preparing CAPAs (Corrective and Preventive Actions), and ensuring timely closure of observations.

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GMP Training

GMP Training

A well-trained workforce is the foundation of a compliant and efficient manufacturing environment. At Micron, we provide structured and customized GMP training programs designed to enhance regulatory understanding, and operational performance across pharmaceutical, cleanroom, and medical device sectors.

Our GMP Auditing Services Include :

  • Cost-Effective & Time-Saving : In-house programs eliminate travel expenses and reduce employee downtime, making them one of the most economical training solutions.

  • Regulatory & Industry Relevance : Our training aligns with the latest global regulatory standards (e.g., US FDA, EU GMP, ISO 13485) and industry best practices.

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Microbiology

Microbiology

Ensuring Sterility, Safety, and Compliance

At Micron, we offer a comprehensive suite of microbiology services tailored to meet the stringent regulatory and quality requirements of pharmaceutical, biotechnology, and medical device industries. Our services are designed to support contamination control, product safety, method validation, and robust environmental monitoring practices.

Review and Optimization of Microbial Testing Procedures Expert review and standardization of microbiological testing protocols such as:

  • Growth Promotion Testing (GPT)

  • Microbial Limit Testing (MLT)

  • Sterility Testing

  • Antimicrobial and Preservative Efficacy Testing (AET/PET)

  • Bacterial Endotoxin Testing (BET/LAL)

  • Water Testing (PW/WFI/RO)

  • Ensuring methods comply with pharmacopial standards (USP, EP, IP) and are audit-ready.

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Regulatory Services

Regulatory Services

  • REMS (Risk Evaluation & Mitigation Strategy).

  • Review of Abbreviated New Drug Application (ANDA) submissions.

  • eCTD authoring and compilation for CEP, DMF, ANDA, GCC submissions.

  • Set-up of Pharmacovigilance Department.

  • 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.

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