GxP Compliance Services for Drug Development

Navigate complex GxP expectations with practical regulatory advisory for clinical trials and drug development. DRK Research Solutions combines scientific, clinical, quality, and technical expertise to help sponsors strengthen inspection readiness, protect data integrity, and move programmes forward with confidence. From dossier review and system validation to mock audits and training, our advisors provide responsive, cost-effective support tailored to your development goals.

Pharmaceutical compliance advisor reviewing clinical trial records

Our GxP Compliance Services

Flexible regulatory and quality support for clinical studies, development programmes, validated systems, and global submission readiness.

GxP Advisory

Tailored compliance guidance from experienced scientists, pharmacists, engineers, and IT specialists to address facility, process, and quality-system requirements across the product lifecycle.

Regulatory Strategy

Support for regulatory documentation, product dossier review, eCTD submissions, and market-access planning to help teams prepare clear, compliant materials for global authorities.

Clinical Trial Operations

Operational oversight from feasibility through final reporting, including ethics and regulatory submissions, site support, monitoring, project management, safety reporting, and investigational product logistics.

Clinical Data Management

Lifecycle data-management support covering validated eCRFs, data review, coding, reconciliation, database audits, lock activities, and regulatory-ready data deliverables for clinical studies.

Study Setup

Build a controlled study foundation through protocol review, timelines, eCRF and edit-check validation, dictionaries, UAT, vendor setup, documentation, and IxRS integration.

Product Development

Advance products with formulation and analytical development, technology transfer, manufacturing support, and compliant eCTD dossier preparation for regulated-market review.

Practical Regulatory Expertise

Compliance Support That Moves Development Forward

DRK Research Solutions helps sponsors translate GxP requirements into workable controls across clinical development and product programmes. Our globally experienced advisors assess gaps, review dossiers, support validated systems, and prepare teams through off-site evaluations, on-site mock audits, and focused training. With a collaborative approach and real-time management response, we tailor the level of support to your risk profile, timelines, and regulatory objectives while protecting confidentiality.

Advisor guiding a clinical team through compliance review
The DRK Difference

Why Choose DRK Research Solutions?

Multidisciplinary guidance designed for complex, global development programmes.

Global Perspective

Worldwide networks and localized proficiency support programmes operating across diverse regulatory environments and markets.

Deep Experience

Over a decade of pharmaceutical development experience informs practical, risk-based compliance recommendations for sponsors.

Integrated Expertise

Clinical, scientific, regulatory, engineering, and IT specialists collaborate to address interconnected quality requirements.

Responsive Support

Management staff provide real-time responses and flexible project support aligned with evolving programme priorities.

Meet the DRK Team

Experienced leaders advancing compliant, patient-centred pharmaceutical development worldwide.

Portrait of Dr. Shahab Q. Khokhar, Executive Director at DRK Research Solutions

Dr. Shahab Q. Khokhar

Executive Director

Dr. Shahab Q. Khokhar serves as Executive Director at DRK Research Solutions SA, bringing strategic leadership and deep pharmaceutical expertise to the organization's global operations. With a career rooted in clinical research and pharmaceutical development, Dr. Khokhar has been instrumental in shaping DRK's growth from a Patient Advocacy Organization into a full-service CRO and CDMO. He provides executive oversight across multi-regional clinical trials, regulatory compliance, and business strategy, ensuring the company upholds the highest GxP and ethical standards. His vision drives DRK's commitment to expanding access to innovative therapies, particularly for underserved populations across LMICs in Europe, the Middle East, Asia, Africa, and the Americas.

Portrait of Azka Wase, Head of Business Development at DRK Research Solutions

Azka Wase

Head Of Business Development

Azka Wase is the Head of Business Development at DRK Research Solutions SA, responsible for driving strategic partnerships and expanding the company's global client base across the pharmaceutical and biopharmaceutical sectors. With a strong foundation in life sciences and commercial strategy, Azka leads efforts to connect sponsors, research institutions, and healthcare partners with DRK's end-to-end CRO and CDMO capabilities. Her work spans DRK's operational regions, including Europe, the Middle East, Asia, Africa, and the Americas. Azka is committed to building meaningful, long-term collaborations that accelerate drug development timelines and ultimately improve patient access to innovative treatments worldwide.

Portrait of Vipan Dhall, Ph.D., Chief Scientific Officer at DRK Research Solutions

Vipan Dhall, Ph.D.

Chief Scientific Officer

Vipan Dhall, Ph.D., serves as Chief Scientific Officer at DRK Research Solutions SA, leading the company's scientific strategy and innovation agenda. With advanced expertise in pharmaceutical sciences, Dr. Dhall oversees the scientific direction of clinical development programs and CDMO services, including generics and hybrid product development for regulated markets. He plays a central role in ensuring that DRK's research methodologies meet the highest standards of scientific rigor and regulatory compliance. Dr. Dhall is passionate about leveraging cutting-edge science and technology to bring therapies to patients faster, consistent with DRK's core value of innovation with purpose and its mission to enhance global healthcare access.

Portrait of Dr. Isabel Potani, PhD, Clinical Trials Implementation Specialist at DRK Research Solutions

Dr. Isabel Potani, PhD

Clinical Trials Implementation Specialist

Dr. Isabel Potani, PhD, is a Clinical Trials Implementation Specialist at DRK Research Solutions SA, bringing specialized expertise in the design, coordination, and execution of clinical trials across diverse international settings. With a particular focus on multi-regional clinical trials, Dr. Potani ensures rigorous implementation standards are maintained from site initiation through study completion. Her background and dedication to patient-centric research make her especially effective in trials targeting underserved and LMIC populations. Dr. Potani collaborates closely with global sponsors, site investigators, and regulatory bodies to deliver high-quality clinical data while prioritizing participant safety and study integrity throughout every phase of the trial process.

Portrait of Dr. Zenaida Reynoso-Mojares, Chief Medical Officer at DRK Research Solutions

Dr. Zenaida Reynoso-Mojares

Chief Medical Officer

Dr. Zenaida Reynoso-Mojares serves as Chief Medical Officer at DRK Research Solutions SA, providing senior medical leadership across the company's clinical development portfolio. With extensive experience in clinical medicine and pharmaceutical research, she oversees medical strategy, patient safety, and the medical integrity of DRK's clinical trial programs from Phase II through Phase IV. Dr. Reynoso-Mojares ensures that all clinical activities adhere to the highest GxP, ethical, and regulatory standards across DRK's global operational regions, including Europe, the Middle East, Asia, Africa, and the Americas. Her patient-centric philosophy aligns with DRK's core mission of improving healthcare access for underserved populations worldwide.

Portrait of Dr. Onesmo Mpanju, Regional Head USA & Africa at DRK Research Solutions

Dr. Onesmo Mpanju

Regional Head – USA & Africa

Dr. Onesmo Mpanju is the Regional Head for USA & Africa at DRK Research Solutions SA, leading the company's strategic operations and business development activities across two of its most impactful regions. With a strong background in pharmaceutical research and regional healthcare systems, Dr. Mpanju manages DRK's presence at its Aldie, Virginia office while fostering key relationships with sponsors, research institutions, and healthcare partners across the African continent. His expertise in navigating diverse regulatory environments and his dedication to expanding clinical research capabilities in underserved African markets directly support DRK's mission to enhance global healthcare access, particularly for low- and middle-income country populations.

Portrait of Dr. Zafar Mirza, Senior Strategic Advisor at DRK Research Solutions

Dr. Zafar Mirza

Senior Strategic Advisor

Dr. Zafar Mirza brings distinguished expertise to DRK Research Solutions SA as Senior Strategic Advisor, providing high-level guidance on global health policy, regulatory strategy, and pharmaceutical development. With a career spanning international health organizations and pharmaceutical research, Dr. Mirza offers invaluable insight that helps shape DRK's long-term strategic direction. His advisory role supports the company's mission to bridge global healthcare gaps and improve access to modern treatments, particularly in underserved regions. Dr. Mirza's deep knowledge of global regulatory landscapes and his commitment to equitable healthcare access make him a cornerstone of DRK's leadership team and an essential voice in the company's patient-centric philosophy.

Portrait of Dr. Nigel Whittle, Country Head UK at DRK Research Solutions

Dr. Nigel Whittle

Country Head UK

Dr. Nigel Whittle serves as Country Head UK for DRK Research Solutions SA, overseeing all operations and business activities from the company's Cambridge, United Kingdom office. With extensive experience in the UK pharmaceutical and clinical research landscape, Dr. Whittle manages local stakeholder relationships, regulatory engagements, and business development across the United Kingdom and broader European markets. He ensures that DRK's UK operations maintain the highest standards of compliance and service delivery consistent with the company's global reputation. Dr. Whittle's localized expertise combined with DRK's worldwide capabilities enables seamless delivery of CRO and CDMO services to pharmaceutical and biopharmaceutical clients across Europe.

Portrait of Muhammad Mazree, Regional Head Southeast Asia at DRK Research Solutions

Muhammad Mazree

Regional Head - Southeast Asia

Muhammad Mazree is the Regional Head for Southeast Asia at DRK Research Solutions SA, directing the company's operations and growth strategy from its Shah Alam, Selangor, Malaysia office. With deep knowledge of the Southeast Asian pharmaceutical market, regulatory environment, and clinical research ecosystem, Muhammad manages key regional partnerships and oversees business development activities across this dynamic and rapidly growing market. He ensures that DRK's global CRO and CDMO capabilities are effectively delivered to local pharmaceutical and biopharmaceutical clients while maintaining the company's exacting standards of quality and compliance. His regional leadership is critical to DRK's mission of expanding healthcare access across Asia.

Portrait of Krishnaveni Thanappan, Clinical Data Manager at DRK Research Solutions

Krishnaveni Thanappan

Clinical Data Manager

Krishnaveni Thanappan is a Clinical Data Manager at DRK Research Solutions SA, specializing in the collection, management, and quality assurance of clinical trial data across DRK's global studies. With expertise in data management systems and regulatory-compliant processes, Krishnaveni ensures the integrity, accuracy, and completeness of clinical data from trial initiation through database lock. Her meticulous approach supports DRK's commitment to delivering high-quality evidence that meets the rigorous standards of global regulatory agencies. Krishnaveni works collaboratively with clinical operations, biostatistics, and sponsor teams to maintain seamless data flows, contributing directly to the success of multi-regional clinical trials and the advancement of innovative pharmaceutical therapies.

Portrait of Maha Fareed, Lead PMD & OD at DRK Research Solutions

Maha Fareed

Lead PMD & OD

Maha Fareed serves as Lead Project Management & Organizational Development (PMD & OD) at DRK Research Solutions SA, driving the effective planning, execution, and delivery of the company's complex pharmaceutical and clinical research projects. With a strong background in project management and organizational development, Maha ensures that DRK's cross-functional teams operate with efficiency, cohesion, and strategic alignment across its global offices. She plays a vital role in building internal capabilities and streamlining processes that support timely project delivery—one of DRK's key competitive advantages. Maha's commitment to fostering a diverse, inclusive, and high-performing workplace reflects DRK's core values and its vision for sustainable organizational growth.

Frequently Asked Questions

What does GxP compliance mean?

GxP compliance means working in accordance with applicable “Good Practice” standards that protect product quality, patient safety, data integrity, and traceability. The specific requirements depend on the activity, such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), or Good Laboratory Practice (GLP). Compliance is demonstrated through controlled processes, trained personnel, complete documentation, risk management, oversight, and readiness for inspection.

What does GxP stand for?

What are the five Ps of GxP compliance?

Does a GxP system need to be validated?

Which GxP areas apply to clinical trials?

When should GxP compliance planning begin?

What happens during a GxP mock audit?

How can regulatory advisory support a drug-development programme?

Need Answers for Your Development Programme?

Speak with our advisors about practical, risk-based compliance support.

Trusted Development Partner

Awards and Recognition

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GxP Standards Focus

Commitment to rigorous quality and ethical practices.

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Global Regulatory Experience

Advisory experience across major global regulatory pathways.

Patient-centred development emblem

Patient-Centred Development

Focused on access to innovative therapies.

Bring Clarity to Your GxP Strategy

Tell us about your programme, compliance challenge, and timeline. Our team will help identify focused next steps.

Contact Us Today

For immediate assistance, feel free to give us a direct call at +41 76 797 25 67. You can also send us a quick email at info@drkresearch.com.