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📞 Connect with iViTAA CONSULTANCY
Navigate complexity. Accelerate compliance. Expand globally.
Navigate complexity. Accelerate compliance. Expand globally.
At IVITAA CONSULTANCY, our Regulatory Affairs services are tailored for pharmaceutical, nutraceutical, food, and cosmetic companies seeking to access Rest of World (ROW) markets. We provide strategic guidance, technical documentation, and hands-on support to meet diverse regulatory frameworks and country-specific requirements.
At IVITAA CONSULTANCY, our Regulatory Affairs services are tailored for pharmaceutical, nutraceutical, food, and cosmetic companies seeking to access Rest of World (ROW) markets. We provide strategic guidance, technical documentation, and hands-on support to meet diverse regulatory frameworks and country-specific requirements.
Our Regulatory Expertise Includes:
Our Regulatory Expertise Includes:
Comprehensive Regulatory Support
Full-spectrum support for APIs, formulations, new drug registrations, generics, clinical trial documentation, GMP standards, variation filing, and post-market surveillance.
Comprehensive Regulatory Support
Full-spectrum support for APIs, formulations, new drug registrations, generics, clinical trial documentation, GMP standards, variation filing, and post-market surveillance.
Product Registration & Dossier Management
Preparation and submission of Non-CTD, CTD, and ACTD dossiers. Expert handling of authority communications, including FDA query responses and country-specific documentation protocols.
Product Registration & Dossier Management
Preparation and submission of Non-CTD, CTD, and ACTD dossiers. Expert handling of authority communications, including FDA query responses and country-specific documentation protocols.
Clinical Trial Oversight (BE Studies)
Guidance through ethical submissions, protocol design, and documentation for countries requiring clinical and bioequivalence data.
Clinical Trial Oversight (BE Studies)
Guidance through ethical submissions, protocol design, and documentation for countries requiring clinical and bioequivalence data.
Quality & Manufacturing Compliance
Support in aligning QMS and manufacturing practices with regional standards for regulatory acceptance.
Quality & Manufacturing Compliance
Support in aligning QMS and manufacturing practices with regional standards for regulatory acceptance.
Labeling & Packaging Compliance
Regulatory review of product labeling, packaging elements, and regional-specific declarations for each target market.
Labeling & Packaging Compliance
Regulatory review of product labeling, packaging elements, and regional-specific declarations for each target market.
Import/Export Regulatory Assistance
Navigation of cross-border procedures including documentation, clearance, and regulatory import/export requirements.
Import/Export Regulatory Assistance
Navigation of cross-border procedures including documentation, clearance, and regulatory import/export requirements.
Authority Liaison & Stakeholder Engagement
Building strong working relationships with in-country regulators to streamline market entry and post-approval processes.
Authority Liaison & Stakeholder Engagement
Building strong working relationships with in-country regulators to streamline market entry and post-approval processes.
Regulatory Training & Intelligence
Conducting seminars and knowledge sessions to keep client teams informed about evolving regulatory trends and policy updates.
Regulatory Training & Intelligence
Conducting seminars and knowledge sessions to keep client teams informed about evolving regulatory trends and policy updates.
Pharmacovigilance & Post-Market Surveillance
Structuring systems for adverse event reporting, ongoing product monitoring, and regulatory compliance after launch.
Pharmacovigilance & Post-Market Surveillance
Structuring systems for adverse event reporting, ongoing product monitoring, and regulatory compliance after launch.
Specialized Categories Support
Food & Nutraceuticals: Compliance with safety, labeling, and nutrition regulations.
Cosmetics: Ingredient validation, safety assessments, and compliant labeling.
Specialized Categories Support
Food & Nutraceuticals: Compliance with safety, labeling, and nutrition regulations.
Cosmetics: Ingredient validation, safety assessments, and compliant labeling.
Target Markets:
Expertise in emerging and semi-regulated markets, including Brazil, Mexico, South Africa, and LATAM regions.
Target Markets:
Expertise in emerging and semi-regulated markets, including Brazil, Mexico, South Africa, and LATAM regions.
We simplify global compliance so your innovations can reach patients faster—with confidence and credibility.
Have a Compliance Challenge?
Let’s Solve It — Together.
All consultations are strictly confidential and handled by senior regulatory experts
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