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Our Services

Our expertise in regulatory requirements along with technical knowledge, enables ANP Pharma (London) Limited to provide a range of consulting services for analytical research and quality Assurance (QA) in the Pharmaceutical Industry.

1. Analytical Research and Development

  • Complete analytical Program Design
  • Laboratory Design and Instrumentation
  • Validation Planning & Design

2. Quality Assurance (QA)

  • Data Envelopment Analysis (DEA)
  • On-site Good Manufacturing Practice (GMP) /Good Laboratory Practices (GLP) /Good Distribution Practices (GDP) Training
  • Quality Management System
  • Regulatory Affairs
Pharmaceutical Regulatory Affairs Services
      • Dossier/submission preparation or review and filing
      • Development of regulatory strategy for the product’s life cycle
        • Consideration of international regulatory requirements
        • Meeting international filings
        • Revision of plans as guidelines change
      • Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process
        • Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
        • Respond to regulatory agency questions
      • Provide expert regulatory CMC compliance advice throughout development
      • Work with Sponsors and regulatory authorities through the resolution of complex development issues
      • Assist with due diligence activities for investors/licensees
Pharmaceutical Product Development Services
      • Comprehensive product development strategies meeting international standards, focusing on regulatory and toxicology requirements
        • Nonclinical studies required for next phase of Clinical Development
        • Management of Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, etc.
        • Timing and requirements for regulatory submissions to support on-going development activities
      • Preparation, review, management and filing of submissions worldwide in Common Technical Document (CTD/eCTD) format
        • Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, Integrated Summaries, etc.
      • Scientific writing of nonclinical data (safety), clinical data, and preparation of CMC documents
      • Manage nonclinical programs and Quality (CMC) components, and facilitate clinical programs to support registrations worldwide
      • Compliance activities, including development of compliance programs and conduct of facility for adherence to GLP and GMP standards

3. Supplier qualification and on-site GMP/GLP/GDP Audits

  • Pharmaceutical Inspections
  • Pharmaceutical Auditing for OTC Drugs
  • Supply Chain Program Management

4. Validation Support (Development, Planning and Equipment)

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