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Pharmaceutical (Global page)

Bringing data science and human science together to advance human health and support the pharmaceutical industry from clinical trials to commercialization.

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Consumer Health

Connecting with powerful, evidence-based market insights to drive agile thinking, uncover growth potential, and gain competitive advantage in this fast-moving consumer health market.

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MedTech

Empowering to orchestrate operations across the entire product lifecycle, from concept-to-market, providing quality control, regulatory, safety and compliance solutions along the way.

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Public Health & Government

Working across the health system to address key barriers to deliver high-quality, cost-effective care while improving health outcomes using our data-driven and population-centric solutions.

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Delivering a wide range of consulting and technology solutions to support healthcare stakeholders to drive operational efficiency, enhance quality of patient care, and improve systemic outcomes.

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Research & Development (Global page)

Clinical development enabled by Connected Intelligence™ which combines data and analytics with deep therapeutic and operational expertise to improve efficiency, enhance precision, and bring therapies to patients faster.

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Real World Evidence

Harness the power of real-world data and insights to demonstrate value-driven evidence and outcomes to meet stakeholder needs across the healthcare ecosystem and to propel healthcare forward.

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Information Insights

Pharmaceutical market data and information assets that provide actionable data points to help organizations make intelligent connections and drive healthcare forward.

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Market Research

Primary Intelligence integrates purpose-built and syndicated research solutions with our wide range of data assets, research methodologies, advanced analytics, and deep domain expertise, generating quality insights for our clients.

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Strategy Consulting (Global page)

Trusted advisor and partner to global healthcare organisations, solving the most significant business challenges through extensive healthcare expertise.

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Contract Sales & Medical Solutions (Global page)

Optimize commercial success by leveraging our comprehensive outsourced expertise to accelerate time-to-market.

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Patient Solutions (Global page)

A single window solution provider to support pharmaco’s design, deploy technology and services that help increase access to medicine and improve treatment adherence.

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Connected Intelligence™, digital insights, data analytics and advanced technology to power smarter decision-making to enable better patient outcomes and improved business results.

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Get the latest insights on our life sciences, healthcare, and medical technology solutions in Asia Pacific. 

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IQVIA APAC Insight

"A curation of IQVIA's best thinking on topics and trends driving change, disruption, and progress in the Asia Pacific healthcare market.

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"Unlocking the Future of Consumer Health: A Special Focus on Senior Consumers

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APAC FOOTPRINT

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COMMERCIAL REGULATORY SERVICES

Accelerate regulatory approvals. Ensure regulatory compliance.

Did you know that early entrants on average can achieve higher market share even 10 years after launch? Hence, it’s vital to have regulatory planning early and strategize which market in Asia Pacific would give you the best return on investment (ROI) based on early regulatory approval. IQVIA Commercial Regulatory Services is well-positioned to expedite market access of products through our strategic regulatory recommendations and end-to-end regulatory expertise support, thereby helping our clients thrive in this dynamic environment.

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Locations Asia Pacific Commercial Regulatory Services

Your one-stop partner to navigate through regulatory complexities​

Life sciences companies often face regulatory challenges when seeking market access for their products across the region. Traversing the complex and diverse regulatory frameworks of different countries can be challenging, especially for novel products without regulatory precedents.

The IQVIA APAC Commercial Regulatory Services team aims to provide client-focused delivery of regulatory services to support pharmaceutical and life sciences companies, including emerging biopharma and MedTech start-ups in the region throughout the entire product regulatory approval cycle, from marketing applications to lifecycle development. Some of our key offerings include innovative regulatory strategies, product development plans, pivotal engagements with health authorities, and the mobilization of up-to-date regulatory intelligence.

A holistic suite of offerings that provide end-to-end strategic and operational regulatory support throughout the entire product lifecycle

IQVIA Commercial Regulatory Services manages a diverse portfolio of healthcare products for pharmaceutical and life sciences companies. We offer a comprehensive range of solutions to assist our clients in bringing products from bench to bedside, ensuring the best optimal route to expedite market access through approvals. Our services include regulatory roadmaps, product gap analysis, technical due diligence, oversight of CMC changes, product license renewals, and more, providing strategic advice on business continuity programs throughout various phases of the product lifecycle.

Pharmaceutical products

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Medical devices

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Consumer health products

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Pharmaceutical products

We provide end-to-end regulatory support for registration and launch of pharmaceutical products including new drugs, biosimilars, generics, vaccines, cell and gene products, and more. Our services cover strategy development, operational support in dossier/documents preparation and registration, compliance with submission requirements, and product maintenance throughout the lifecycle management process.

Pharmaceutical products

From pre-NDA to post-approval, our team is well-equipped to assist you in propelling your product from lab to market. We work closely with a diverse group of clients to construct strategic solutions that meet regulatory needs and shorten the time frame from product application to approval. Some examples of regulatory solutions that we provide include, but are not limited to:

  • Regulatory advice on product quality development (inclusive of CMC requirements)
  • IND and NDA dossier gap analysis and preparation
  • Post-approval obligations support (local ADR reporting, support in pharmacovigilance audit)
  • Promotional material reviews

These solutions have been used to successfully deliver marketing approvals for products, such as cell gene therapies, first-in-class molecules, radiopharmaceuticals, biosimilars and generics.

Strategic Intelligence: Country market screening and selection

We support the evaluation of regulatory requirements and barriers for product launches in different markets/countries by providing both commercial and regulatory considerations, as well as developing effective strategies for selecting which Asian market to enter first.

Pre-new drug application (NDA) solutions

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Regulatory advice on product quality development, including CMC requirements
  • Advice on clinical development programs and trial designs, including comparator arms, population and subgroups of interest, and considerations for multi-regional clinical trials (MRCT) or local bridging studies
  • Local pharmacovigilance needs, including additional risk minimization measures and post-marketing surveillance study protocols
  • Investigational new drug (IND) dossier gap analysis, preparation and submission
  • Interaction with health authorities about study designs
Health Authority Interactions

Engaging and communicating effectively with health authorities is crucial for navigating the regulatory landscape and ensuring compliance with regulations. We have extensive experience in:

  • Developing strategic questions prior to health authority meetings
  • Providing coaching and guidance for health authority meetings, including briefing preparation
  • Interpreting health authority responses by leveraging our regulatory expertise in each local country
  • Advising on the next steps after meeting with the health authority

NDA (new drug application), MAA (market authorization application) submissions

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Regulatory intelligence and strategic advice on application procedures and review pathways
  • NDA dossier gap analysis and preparation
  • Regulatory advice on reference products and biopharmaceutics classification system (BCS) bio-waivers for generic medicines; comparability studies for biosimilars
  • Good manufacturing practice (GMP) documentation review
  • Review of labelling scientific content against clinical data
  • Local quality control (QC) testing support
  • Review of local pharmacovigilance documents, e.g., risk management plans and post-marketing surveillance study protocol
  • Pre-submission meeting representation and discussion with health authorities

Post-approval lifecycle management

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Post-approval obligations support, e.g., local adverse drug reaction (ADR) reporting and support in pharmacovigilance audit
  • Compliance and maintenance of marketed products, variation application and product renewals
  • Promotional material review

Supporting the registration of an oral drug in select SEA markets

Situation
  • The client is a China-based company that specializes in discovering, developing and commercializing cancer and autoimmune drugs. The client wanted to find out if the China NMPA approval is accepted in select SEA markets, with the intention to market the product after regulatory submission and approval. 
Solution

The following steps were taken:

  • Market regulatory landscape (NDA/MAA approvals)
  • Regulatory gap analysis (existing NDA package deficiencies)
  • NDA dossier preparation (select markets)
  • MAH vendor liaison for product launch
Result
  • The client was provided with recommendations on countries, gap analysis, regulatory roadmaps and dossier preparation

Evaluation of regulatory requirements for oncology products in global markets ​

Situation
  • A Japan-based pharma client was looking for a vendor to assess the acceptability of single-arm studies and identify the critical regulatory barriers for obtaining marketing authorization of their oncology product in global markets.
Solution

IQVIA provided a high-level assessment of:

  • Acceptability of single-arm trials for marketing authorization
  • Evaluation of the oncology product based on the current single-arm evidence package
  • Regulatory barriers that may delay or prevent marketing authorization approval
  • Availability of adjunctive treatment (included as example of a product developed with a single-arm study)
Result
  • The client was provided with IQVIA’s analysis that could help them prioritize countries for their marketing authorization submissions based on the likelihood of success.
 

Medical devices

We provide a one-stop solution for regulatory support in medical device registration and launches. Our services cover strategy development, operational support in document preparation and registration, compliance with submission requirements, new company setup for product importation, and product maintenance throughout the lifecycle management process.

Medical devices

We provide a wide range of regulatory services to help bring your medical devices into the Asia Pacific markets.

From product classification and claims to licensing and importation requirements, we can support you in navigating the complex local regulatory environment to achieve a faster speed to market. We leverage our unique on-the-ground expertise, scientific KOL networks and proprietary regulatory intelligence databases to achieve the best regulatory outcome for our clients. Our expertise covers various products, including Software as a Medical Device (SaMD), in-vitro diagnostics (IVD), and device-drug combination products.

Pre-registration

Our comprehensive range of services include regulatory strategy, device classification, quality management, health authority consultation and regulatory submission for medical devices, drug-combination devices, IVD and SaMD.

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Advice on clinical trial-related regulations and requirements for medical devices
  • Advice on product registration strategy, including country-specific requirements, technical documentation gap analysis, labelling requirements, quality management system (QMS) requirements
  • Advice on local authorized representative/establishment, importation and distribution requirements
  • Support on interaction with health authorities about submission pathways and clinical requirements
  • Advice on regulatory environment, trends and impact analysis of recent or potential regulation changes

Device registration

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Technical dossier gap analysis and preparation
  • Support local dossier compilation (STED, ASEAN CSDT), device classification, grouping and labelling requirements
  • Pre-submission meeting representation and discussion with health authorities
  • Review GMP/ISO 13485 requirements based on country-specific needs
  • Provide support and strategic guidance in responding to health authority queries

Post-approval lifecycle management

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Advice on regulatory strategy and execution for line extensions and device lifecycle changes
  • Support on license renewals and license transfers
  • Support on post-market surveillance requirements, such as adverse events reporting, recalls and field corrective actions (FCA)
  • Support and advice on advertisement requirements and control

Understanding CDx approval pathway for oncology products​

Situation
  • The client was interested in understanding how other companies approached regulatory approval for companion diagnostics (CDx) in key APAC markets, with a focus on Japan, Australia and Korea.
Solution
  • IQVIA’s regulatory experts aimed to provide a baseline understanding of the regulatory process for CDx by leveraging previous project findings and conducting extensive research through interactions with industry, local regulatory and CDx experts. Key success factors, challenges, processes, timeline and filing strategies for analogue products were identified and used to develop case studies on select analogues and their CDx approval pathways.
Result
  • An engagement roadmap, global filing strategy and filing sequences supported by case studies of the CDx approval pathway for Japan, Australia and Korea were recommended to the client, together with derived learnings.
 

Consumer health products

We provide comprehensive regulatory support for claims, registration, and launch of consumer health products, including OTCs, cosmetics, food, and more. Our services cover strategy development, operational support in product classification, claims analysis, and recommendations, Rx to OTC switch, product registration, compliance with submission requirements, preparation of promotional materials, and product maintenance throughout the lifecycle management process.

Consumer heath products

With an in-depth understanding of the consumer healthcare industry spanning across over-the-counter (OTC) medicines, vitamins/health supplements, nutritional and personal care products, our team is well-suited to assist your company through regulatory challenges.

You can rely on our comprehensive suite of unique data and insights, as well as our robust understanding of the consumer care category, to help you launch your products effectively, compete against your rivals, and uncover customer insights to accelerate product approval. Additionally, other products that fall under our scope of expertise include food, wound care and cosmetics.

Pre-registration solutions

Our offerings include OTC products, health supplements, natural products, medical functional foods, nutraceuticals and cosmetics etc.

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Regulatory landscaping and assessment
  • Claim evaluation – science-based, literature analysis
  • Claim substantiation
  • Claim feasibility assessment
  • Regulatory strategies
  • Formulation and technical assessment

Registration submission

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Regulatory assessment
  • Prescription to over-the-counter (Rx-to-OTC) switches
  • Health authority consultations and engagement
  • Claims and labelling assessment
  • Support in registration applications, notifications and ingredient assessment

Post-approval lifecycle management

Some examples of regulatory solutions that we provide include, but are not limited to:

  • Compliance to local regulations
  • Regulatory environment monitoring
  • Chemistry, manufacturing and controls (CMC) changes
  • Pack design, labels and claims updates
  • Renewals
  • Advertisement and promotional material review

From prescription to over-the-counter

Situation
  • Client was interested in exploring early-stage stakeholder support for the complex switch of a cardiology product from Rx to OTC status and developing a switch strategy.
Solution
  • IQVIA’s APAC regulatory experts designed and facilitated a key switch expert workshop to generate insights and consensus on potential switch options. The expert opinions and sharing to implications in the country/market were then discussed in the management workshop to develop action steps and a product switch development plan.
Result
  • Our deliverables played an instrumental role in the client’s decision to proceed with the application for an Rx-to-OTC switch.

Milking the most of dairy

Situation
  • A leading company and producer of dairy ingredients was interested in identifying partners to increase the volume and value of two of their probiotic strains in South Korea, as well as to understand the current regulations and permitted functional claims.
Solution
  • IQVIA’s APAC regulatory experts helped the client map out the regulatory requirements in South Korea, U.S. and Australian markets by conducting an in-depth analysis of the regulatory environment.
  • A claims framework and substantiation assessment criteria were developed to rank claims based on their level of acceptability (high, medium, low) using a traffic light system.
Result
  • We provided recommendations and a summary of the most appropriate claims to be used for on-pack advertising, promotional and marketing communications.
IQVIA’s Regulatory Expertise

70+ CLIENTS IN APAC RHQ

across clinical/IND/CMC services, regulatory strategies, marketing applications, and lifecycle maintenance, covering product areas such as medical devices, pharmaceuticals, OTC products, cell and gene therapies

IQVIA’s Regulatory Expertise

OVER 20 YEARS

Our consultants come from diverse regulatory backgrounds including research, academia, health authorities and industry.

OUR CAPABILITIES

Tarius Regulatory Intelligence

Keeping up with regulatory requirements can be challenging, especially when they vary from country to country and are constantly evolving. With IQVIA’s Tarius Regulatory Intelligence, you can always ensure compliance with confidence.

Some features of IQVIA’s proprietary Tarius Regulatory Intelligence include:

  • Global coverage
  • Access to health authority documents
  • Cross-country comparisons
  • Summaries of regulatory parameters

Additional services to support and complement end-to-end regulatory approvals

Here are some examples, but they are not limited to:

Client Feedback to Our Team

Head of Regulatory, MNC

“IQVIA provided us with a lot of valuable insights and information, which are truly helpful and necessary for our company to plan our next steps.”

CEO, China-based company

“Thank you IQVIA Regulatory Team for your client-centric work and innovation approach that has led to the successful registration and approval of our licensed product in SEA.”

Client Regulatory Head, SEA and ANZ

“Thank you for your extra effort in finding local key opinion leaders to assist us with the unmet medical need during the priority review of product registration.”

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Our Latest Thinking

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Securing Sustainable Reimbursement for Cell and Gene Therapies

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How to Manage Complexity in Cell and Gene Therapy Clinical Trials (JAPAC)

BLOG
Navigating the Diverse Cell, Tissue, and Gene Therapy Landscape in Japan and Asia Pacific (JAPAC)

Blog
Forging a New Path in Innovative Clinical Trial Design (ICTD) for Cell and Gene Therapies

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