Regulatory Services : Pharmaguideline

Online GMP Courses with Certificate


Regulatory Services


We help in maintaining QMS Documents.

  • Standard Operating Procedures (SOPs) for all departments of pharmaceutical manufacturing units.
  • Validation Protocols
  • QMS Documents
  • IQ, OQ, PQ of all instruments/equipment
  • Audit Checklists for all departments

Plant Setup

Our team will visit your site & understand what type of plant you want to set up. We then provide you map, provide the source of the machine, supervise construction & machine installation & in the end successfully get you the license. Pharmaguideline can provide complete consultancy to set up oral dosages and injectable plants.

  • Oral Dosages Plant
  • Injectable Plant

Regulatory Compliance

Pharmaguideline can help you prepare entire technical document for drug product registration in various countries all over the world.

  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Investigational New Drug Application (IND)
  • CTD Dossier
  • GMP Audit/ Gap Analysis/ Gap Closures services
  • Regulatory Compliance Services


  • Computer System Validation
  • Data Integrity
  • Quality Risk Management
  • Audit behavior/FDA audit readiness
  • Cleaning Validation /Process validation
  • CAPA
  • Investigations
  • Technology Transfer/Stability Study
  • Human Error/Quality culture development
  • On-demand training as per customer requirement

We are experienced pharmaceutical consultants and our pharma consultancy services are in above mentioned areas including regulatory consulting services as a regulatory compliance consultant.

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QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
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Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...



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