- Profile
- Services
- Drug Development services
- Functional services
-
Regulatory Affairs
- Clinical Monitoring
- Site and Patient Recruitment
- Biostatistics and Programming
- Clinical Data Management
- Medical Writing
- Pharmacovigilance
- QA & Compliance
- PharmCenter
- Consulting
- Informatics
- Therapeutic Areas
- Physicians & Investigators
- Patients & Volunteers
- Careers
- News & Events
- Regulatory Affairs:
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MakroCare provides global regulatory affairs expertise to streamline submission management and achieve fast product approval.
Approval Strategy
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Development
planning
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Advisory
boards
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Agency
meetings
-
Submission
strategy
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Due
diligence & data evaluations
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Japanese
regulatory strategy & advice
Submission Management
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IMPDs
and CTAs
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INDs
-
Drug
Master Files
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Marketing
Authorisations (MAAs, NDAs, BLAs)
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Translations
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Variations
and Renewals
Electronic Publishing (CTD and eCTD)
Regulatory Compliance
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Development
of integrated Project Quality Plans
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GLP,
GMP and GCP compliance audits
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Mock
and Pre-Approval Inspections
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Review
and assessment of corrective actions
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Design
and delivery of Quality System training
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Due
diligence in support of in-licensing and out-licensing activities
