Generics & Wellness Products
Integrated BA/BE, clinical and bioanalytical solutions delivered through ethical, quality-controlled and regulatory-aligned processes.
Start a conversation ↗Penang, Malaysia · Southeast Asia
Clinical evidence.
Built with confidence.
An integrated Malaysian CRO and bioequivalence centre helping sponsors generate robust evidence, navigate regional requirements and accelerate access to affordable medicines.
Regional CRO expertise
80+ yearsCollective industry experience across our technical teamAbout Questra
One partner from first protocol to final report.
Founded in Malaysia, Questra is a full-service Contract Research Organisation supporting clients across the product-development journey.
Our name reflects our corporate vision: QUality and Excellent Services in clinical TRial Administration. We combine an integrated research centre, experienced teams and client-focused execution to create reliable evidence for regulatory and commercial decisions.
Discover our centreOur solutions
Evidence built around
your product.
↗
Pharmaceuticals, Medical Devices & Biosimilars
Product-focused clinical development and evidence-generation support, from study strategy through operational delivery and reporting.
Natural Products & Food
Ethical clinical evaluation and fit-for-purpose evidence supporting safety, tolerability, product development and applicable regulatory needs.
Stem Cell & Gene Therapy
Scientific, operational and regulatory support for advanced-therapy programmes, structured around product-specific risks and pathway requirements.
Personal Care & Hygiene Products
Clinical and consumer evidence designed to establish product performance, tolerability and confidence for market development.
Scientific depth
Designed for real development challenges.
Questra supports more than routine execution. Our approach connects clinical operations, bioanalysis, regulatory science and reporting around the evidence your product actually needs.
Standard & complex BE
Conventional, replicate and partial-replicate designs, including highly variable drugs and challenging formulations.
Hybrid & FDC pathways
Scientific and regulatory support for fixed-dose combinations, bridging strategies and products requiring tailored evidence packages.
Clinical pharmacology
PK/PD strategy, DDI evaluation, early-phase execution and specialised analytical planning.
Advanced bioanalysis
LC–MS/MS method development, validation and sample analysis for small molecules, with expansion into specialised platforms.
One-stop research centre
Clinical and bioanalytical expertise, together.
Questra Bio-Clinical Research Centre is a stand-alone research facility for clinical research and BA/BE studies in Malaysia. The centre operates under the Private Healthcare Facilities and Services Act 1998 and is listed in the NPRA Bioequivalence Centre Compliance Programme.
190+Methods developed & validated by the bioanalytical team
1 siteIntegrated clinical facility and bioanalytical laboratory
End-to-end delivery
A connected path to marketing authorisation.
Customisable services designed around your molecule, development stage and submission strategy.
- 01Study design & protocol development
- 02Bioanalytical method development & validation
- 03Healthy-volunteer recruitment & clinical conduct
- 04Ethics and regulatory submissions
- 05Pharmacokinetic & statistical analysis
- 06ICH E3-aligned final study reporting
One accountable partner
From development question to regulatory evidence.
Plan
Feasibility, development strategy, study design and protocol
Prepare
Ethics, regulatory submissions, sites and volunteer recruitment
Execute
Clinical conduct, monitoring, safety and sample management
Analyse
Bioanalysis, data management, biostatistics and PK
Deliver
Integrated reporting, submission-ready outputs and archiving
Malaysia · ASEAN · Global sponsors
A regional platform, anchored in Malaysia.
Questra’s Penang base combines Malaysia-led clinical and bioequivalence operations with a wider Southeast Asian outlook. We aim to give sponsors a responsive local partner that understands regional execution while working to internationally recognised quality standards.
MalaysiaSingaporeIndonesiaThailandVietnamGlobal sponsors
Strategic direction
Building the next generation of clinical intelligence.
Questra’s development vision is to evolve beyond a traditional CRO into an AI-enabled research ecosystem—combining scientific judgement, integrated data and automation to make studies smarter, faster and more predictable.
Future-facing initiativesSmarter study planning
Protocol-risk detection, feasibility intelligence and enrolment prediction to identify operational challenges earlier.
Connected trial oversight
Risk-based monitoring, deviation signals and harmonised study data to support better decisions throughout execution.
Evidence beyond the study
Longer-term development toward real-world evidence, AI-assisted imaging and integrated clinical insights.
Who we support
Built for ambitious development programmes.
Generic pharmaceutical companiesBiotechnology innovatorsMedical-device developersWellness & natural-product companiesInternational sponsors entering ASEANAcademic & investigator-led research
Participate in research
Healthy volunteers make better medicines possible.
Interested in participating in an upcoming BA/BE study at our Penang research centre?
Register your interestLet’s work together
Bring your next development question to Questra.
Tell us about your product, intended market and evidence needs. Our team can help shape the right clinical, bioequivalence or regulatory pathway.
Study enquiriesmail@questra.com.myTelephone+604 390 0653
Research centreNo. 6, Jalan Desa Pauh,
Taman Desa Pauh, 13700 Permatang Pauh,
Pulau Pinang, Malaysia
Taman Desa Pauh, 13700 Permatang Pauh,
Pulau Pinang, Malaysia