Pharma Planning Co., Ltd.
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PRODUCT LIFECYCLE / GxP / SERVICES

Support Services by Lifecycle Stage

Select a product to see the matching scope of support across the lifecycle.

* Applicable scope varies by product category, plan and region.

See the 4 stages and the scope of support.

SERVICE COVERAGESupport Services for Pharmaceuticals

10Services

  1. NonclinicalNonclinical
    Main applicable standards
    • GLPNonclinical safety studies
  2. Clinical TrialsClinical trial
    Main applicable standards
  3. ApprovalApproval
    Main applicable standards
  4. Manufacturing & MarketingManufacturing & marketing
    Main applicable standards
  1. Development & Regulatory SupportFor pharmaceuticals Nonclinical to approval
  2. GMP ConsultingFor pharmaceuticals Clinical trials to manufacturing & marketing
    Consultation topics
  3. Other GxP ConsultingFor pharmaceuticals All stages
  4. CMC SupportPharmaceuticals & regenerative medicine All stages
  5. Gap AnalysisAll 3 product types All stages
    Consultation topics
    • We have an FDA GMP inspection or a PMDA GMP compliance inspection coming up and want you to check whether our manufacturing site's GMP operations meet the standards.
  6. Engineering SupportAll 3 product types Manufacturing & marketing
  7. Audit ServicesAll 3 product types Clinical trials to manufacturing & marketing
  8. Supplier AuditsAll 3 product types Manufacturing & marketing
  9. CSV SupportPharmaceuticals & regenerative medicine Manufacturing & marketing
  10. FDA Inspection SupportAll 3 product types Approval to manufacturing & marketing
    Consultation topics
    • We have an FDA GMP inspection or a PMDA GMP compliance inspection coming up and want you to check whether our manufacturing site's GMP operations meet the standards.

Select a standard to go to its related page. Lines show the stages each service covers, not their duration. Applicable scope varies by product category, development plan, and manufacturing and sales regions.

CONSULTING FLOW

How Our Consultations Work

We assess your current situation, organize the issues, and propose solutions that fit your goals.

  1. STEP 01Identify the issues

    We interview you about your current operations and the goals you are aiming for.

  2. STEP 02Gap analysis

    We analyze the gaps between regulatory and guideline requirements and your current situation.

  3. STEP 03Proposed solutions

    We organize the issues identified and propose priorities and how to implement them.

All Services

SERVICE

For questions or consultations about our services, please call us or use the contact form.

+81-46-204-5377

Hours: weekdays 9:00–18:00 (JST)

Contact Form

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CONTACT

Call usWeekdays 9:00–18:00 JSTContact Us