FDA Six Systems Compliance
Risk-based gap assessments, system evaluation, and remediation planning across all FDA Six Systems to improve compliance readiness and inspection preparedness.
Costarica Pharmaceuticals is a dynamic and rapidly evolving organization dedicated to serving the needs of the pharmaceutical, nutraceutical and healthcare industry. As a manufacturer and trader of pharmaceutical and nutraceutical products and services, we offer comprehensive support for internal and external audit dossier preparation for regulatory bodies and ROW, GAP analysis, audits, validation, risk management, regulatory support, vendor qualification, and market complaints trainings around the globe.
To ensure we consistently meet our commitments to our customers, we are focused on enhancing our business operations, maintaining transparency in all our activities, and actively listening to the perspectives of everyone involved in healthcare decisions. Our goal is to ensure that people everywhere have access to innovative treatments and quality healthcare.
We support pharmaceutical and life sciences organisations with inspection readiness, quality systems strengthening, regulatory compliance, and sustainable remediation programmes.
Risk-based gap assessments, system evaluation, and remediation planning across all FDA Six Systems to improve compliance readiness and inspection preparedness.
Structured mock inspections covering facilities, documentation, quality systems, data controls, and personnel readiness before regulatory inspections.
Strategic support for response drafting, root cause analysis, CAPA design, remediation planning, and regulatory communication management.
Independent assessments of data integrity, ALCOA+ practices, electronic systems, GxP controls, and 21 CFR Part 11 aligned requirements.
On-site and remote remediation support to address compliance gaps, improve operational discipline, and restore inspection confidence.
Practical training programmes and workshops for leadership, quality, manufacturing, engineering, and support teams.
End-to-end design, review, improvement, and restructuring of Quality Management Systems aligned with USFDA, EU GMP, WHO, and global expectations.
Strategic regulatory support for submissions, agency interactions, compliance documentation, meeting readiness, and market access planning.
Regulatory Support ServicesIn an evolving and highly regulated pharmaceutical landscape, ensuring compliance with globa...
ViewGAP Analysis ServicesCostarica Pharmaceuticals offers comprehensive and professional GAP Analysis services to support p...
ViewValidation Services In the highly regulated pharmaceutical and life sciences industry, validation is not just a compl...
ViewRisk Management ServicesEffective Risk Management in the pharmaceutical industry ensures that patient safety and produc...
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Good Manufacturing Practices (GMP) form the backbone of qual...
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Audit & Compliance Trainings are professionally structured ...
View DetailsSynonyms: Capsicum Extract, Hot Pepper Extract, Chili Pepper Extract, Red Pepper Extract, Capsicum ...
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Synonyms: Withania Somnifera Whole Plant Extract, Indian Ginseng Extract, Winter Cherry Extract, As...
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Synonyms: Withania Somnifera Whole Plant Extract, Indian Ginseng Extract, Winter Cherry Extract, As...
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Lupin Limited
INTAS
Hetero Labs Ltd
Medplus
Validant/eliquent
Salicylate Chemicals
AET Laboratories Private Limited
Lupin Limited
INTAS
Hetero Labs Ltd
Medplus
Validant/eliquent
Salicylate Chemicals
AET Laboratories Private Limited
Partner with Costarica Pharmaceuticals for tailored regulatory support, high‑quality ingredients, and expert training.
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