Qualifyo is a consulting services provider specializing in Supplier Qualification Audits, Compliance Consulting, Regulatory Affairs, Engineering project and validation for the pharmaceutical industry. We offer global support for GMP compliance, facility design, regulatory submissions, and more
Qualifyo was founded in April 2024 with a mission to provide reliable, efficient, and globally compliant services to pharmaceutical businesses.
Qualifyo is headquartered in India, with services extended to clients globally.
We primarily serve the pharmaceutical and biotech industries, as well as related sec-tors such as healthcare and nutraceuticals.
Our blend of industry expertise, highly qualified auditors, customized solutions, and a strong focus on European GMP standards differentiates us from competitors.
Yes, we have extensive expertise in EU GMP compliance and support companies tar-geting the European market
Our team comprises seasoned auditors and consultants with decades of experience in regulatory compliance, quality assurance, and Pharmaceutical engineering projects.
Absolutely! We provide tailored consulting services to help start-ups establish compli-ance frameworks, secure licenses, and navigate regulatory pathways.
Yes, we work with clients across North America, Europe, Asia, and other regions to ensure global compliance and market access.
You can reach us via the Contact Us page on our website or email us directly at bd@qualifyo.com
Yes, Qualifyo operates in accordance with global regulatory standards and employs certified auditors and consultants.
Yes, we handle projects from initial consultation to implementation, ensuring seam-less and efficient execution.
Absolutely! We tailor our services to align with each client’s unique requirements, business size, and market focus.
We sign non-disclosure agreements (NDAs) with our clients and follow strict data protection protocols to ensure confidentiality.
Yes, we provide virtual audits and consultations, leveraging advanced digital tools to meet client needs remotely.
These services involve assessing suppliers for compliance with GMP and regulatory standards to ensure the quality and safety of materials used in pharmaceutical production.
Our auditors are well-versed in EU GMP requirements and conduct audits aligned with regulatory guidelines to identify and address compliance gaps.
Audits cover quality systems, manufacturing processes, facilities, documentation, supply chain management, and regulatory compliance.
Our auditors have extensive experience in conducting GMP audits across various industries and geographies.
Yes, we conduct third-party audits for APIs, excipients, and other raw materials.
We provide audit reports based on prior agreement, ensuring compliance with confidentiality agreements.
We cover suppliers globally, including Europe, North America, Asia, and other regions.
The duration depends on the scope of the audit but typically ranges from 1 to 7 days.
We provide a detailed report highlighting deficiencies and recommendations for corrective actions.
Follow-up audits are conducted to verify the implementation of corrective actions and ensure sustained compliance.
Yes, we conduct mock audits to help suppliers prepare for regulatory inspections
Yes, we can deploy multiple auditors to conduct simultaneous audits for efficient project completion.
Suppliers of APIs, excipients, packaging materials, and intermediates are commonly audited.
Yes, we provide guidance and training to suppliers to ensure they meet regulatory expectations.
Contact us via our website or email us with your audit requirements, and we’ll assist you with the process
We offer GMP certification support, facility design, QMS setup, technology transfer, validation, and more
Yes, we help clients prepare and qualify facilities for EU GMP certification.
Absolutely! We provide consulting on facility layout, equipment installation, and compliance requirements.
We manage equipment qualification, process validation, and other commissioning activities.
We assess existing QMS frameworks and provide recommendations to align with regulatory standards.
Yes, we support technology transfer between sites to ensure regulatory and process alignment.
We provide pre-inspection audits, training, and guidance to prepare for successful inspections.
Yes, we ensure systems and processes comply with data integrity principles, including ALCOA+.
Pharmaceutical, biotech, and related industries benefit from our services.
We provide cost-effective, scalable solutions for small and medium-sized businesses.
Yes, we handle multi-site and multi-region compliance projects efficiently.
Yes, we evaluate suppliers for GMP compliance and quality standards.
We use risk-based approaches, GMP frameworks, and advanced auditing tools.
The timeline depends on the scope but typically ranges from weeks to months.
Yes, we conduct tailored training sessions for your team.
We assist with regulatory submissions, dossier preparation, gap analysis, and lifecycle management for pharmaceutical products across global markets.
Yes, we manage submissions for EU, US and emerging markets, ensuring compliance with specific regional requirements.
We specialize in preparing CTD, eCTD, DMFs, ANDAs, and other regulatory submission formats.
Yes, we help prepare, review, and submit DMFs for APIs, excipients, and intermediates.
Yes, we provide expert responses to agency queries, deficiency letters, and technical questions.
Pharmaceutical, biotech, and healthcare companies benefit most from our expertise.
Yes, we manage regulatory variations, post-approval updates, and compliance with market-specific requirements.
Yes, we assist with clinical trial applications, ethics committee submissions, and regulatory clearances.
Absolutely! We support product registrations, renewals, and amendments throughout their lifecycle.
We use advanced tools, rigorous checks, and expert reviews to ensure complete and accurate submissions.
Yes, we provide training sessions for teams to enhance their knowledge of global regulatory requirements.
We prepare comprehensive launch plans, including registration, dossier submission, and compliance strategies.
Yes, we help secure orphan drug designations by preparing and submitting the necessary documentation.
Yes, we provide end-to-end support for biosimilar registrations, including data evaluation and dossier preparation.
We employ a proactive, risk-based approach tailored to each region’s specific regulatory landscape.
This service supports pharmaceutical companies in obtaining licenses, market entry strategies, and establishing distribution networks globally.
Yes, we facilitate both in-licensing and out-licensing deals for pharmaceutical and healthcare products.
We analyze market potential, regulatory requirements, pricing, and reimbursement strategies to create tailored market access plans.
Yes, we help secure product licenses by preparing and submitting applications to regulatory authorities.
We provide market entry strategies, regulatory guidance, and insights into local distribution channels.
Yes, we identify, evaluate, and establish partnerships with reliable distributors.
Yes, we manage license renewals, extensions, and variations to ensure uninterrupted market presence.
We evaluate market dynamics, pricing regulations, and reimbursement pathways to optimize product positioning.
Yes, we offer insights into competitor products, market trends, and pricing strategies to support decision-making.
Yes, we help implement early access programs and compassionate use policies in line with regulatory guidelines.
Pharmaceutical, biotech, and medical device companies benefit significantly from our expertise.
Yes, we provide guidance on supply chain optimization and logistics management for global distribution.
We coordinate with local regulatory agencies to ensure smooth and timely approval processes.
Yes, we offer post-launch services such as monitoring, compliance updates, and market performance evaluations.
Yes, we specialize in identifying and securing partnerships with European distributors for pharmaceutical products.
Qualifyo follows a systematic, risk-based approach to audits. This includes pre-audit planning, on-site verification, documentation review, staff interviews, and a detailed post-audit report with observations, risks, and recommendations.
The audit scope is determined based on the client’s requirements, regulatory expecta-tions, and the type of supplier or facility being evaluated. We work closely with our clients to define clear objectives for each audit.
Yes, gap analyses are an integral part of our process. They identify areas of non-compliance with GMP and regulatory standards, enabling targeted corrective actions.
Our audits are aligned with EU GMP, US FDA guidelines, ICH Q7, WHO GMP, and other applicable local and international standards.
We audit suppliers of APIs, excipients, intermediates, packaging materials, and raw materials across various regions.
Absolutely. We offer tailored audits that address the client’s specific needs, such as focusing on supply chain risks, data integrity, or equipment qualifications.
Our team is experienced in conducting unannounced audits by ensuring preparedness and flexibility. We coordinate discreetly to meet both regulatory and client expecta-tions.
The audit report includes detailed findings, classifications of observations (critical, ma-jor, or minor), compliance gaps, and actionable recommendations for remediation.
Yes, we offer virtual audits using secure digital platforms for document review, inter-views, and facility walkthroughs when on-site visits are impractical.
Our auditors are experienced in working in multilingual environments and often collaborate with local interpreters to ensure effective communication.
Pharmaceutical, biotech, nutraceutical, API manufacturing, excipients, and packaging industries benefit the most from our audit services.
Data integrity is a critical focus of our audits. We review electronic systems, docu-mentation practices, and adherence to ALCOA+ principles.
We provide additional training, root cause analyses, and follow-up audits to ensure the supplier achieves sustained compliance.
Yes, our global network enables us to conduct multiple-site audits simultaneously, en-suring consistency across all locations.
Depending on the audit scope, the entire process (planning, execution, and reporting) typically takes 2–4 weeks.
We offer training on GMP compliance, regulatory requirements, data integrity, QMS implementation, validation, and technology transfer.
Yes, we design role-specific training for operational staff, quality assurance teams, regulatory affairs personnel, and senior management.
Yes, we offer interactive virtual training programs for clients globally, using online platforms and detailed course materials.
Pharmaceutical manufacturers, API producers, biotech firms, excipient suppliers, and regulatory consulting teams can benefit from our programs.
Compliance training should be conducted annually or whenever there are significant regulatory changes, process updates, or new hires.
Yes, participants receive certificates upon completing our training sessions, which can be used for internal records and regulatory submissions.
We focus on ALCOA+ principles, practical case studies, and ensuring employees under-stand the importance of secure, accurate, and traceable data management.
Yes, we provide on-site training programs customized to the client’s facilities, operations, and challenges.
Yes, our inspection readiness workshops include mock audits, documentation reviews, and real-time Q&A sessions.
We use pre-and post-training assessments, feedback surveys, and practical demonstrations to evaluate participant understanding.
Yes, we have specialized programs for senior management to enhance strategic deci-sion-making in compliance and regulatory operations.
Our programs are offered in English and can be adapted with interpreters for other languages based on the client’s needs.
Yes, we cover ICH guidelines (Q7, Q9, Q10, etc.) in detail, with practical applications for compliance teams.
Our training ensures employees understand regulatory expectations, enabling consistent compliance during inspections.
Yes, we offer subscription-based training services to ensure continuous knowledge updates for our clients.
We share detailed success stories from real-world projects, including supplier qualifications, regulatory submissions, and facility certifications.
Yes, case studies are categorized by service type and can be requested from our Re-sources or Report Library page.
We showcase projects from pharmaceuticals, biotech, API manufacturing, and healthcare industries.
We anonymize sensitive information and obtain client consent before publishing any success stories.
Yes, you can contact us to discuss how we can apply our experience from similar pro-jects to your specific needs.
Yes, we feature examples of successful EU GMP certification projects and their out-comes.
Some case studies are available for direct download from our website, while others can be shared upon request.
Our success stories highlight challenges like regulatory compliance gaps, audit failures, and supply chain risks, along with our solutions.
Absolutely. Our start-up case studies provide insights into cost-effective compliance and operational strategies.
Yes, client testimonials are integrated to add credibility and context to our case studies.
Yes, we encourage satisfied clients to collaborate with us on creating impactful success stories.
Metrics include audit closure timelines, regulatory approval times, compliance improvement rates, and cost savings.
Yes, we provide translations for key case studies to cater to our global audience.
Yes, we feature several technology transfer projects, detailing their challenges and successful implementation.
We regularly add new case studies to reflect the latest achievements and evolving challenges in the industry.
Speak to Our Experts at +91 9898573080
If you have a General enquiry, please drop me an email
Email: bd@qualifyo.com
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