Pharma & Biotech

The pharmaceutical and biotech industries are highly regulated and require navigating strict requirements and extensive R&D.

QbD Group offers the expertise to help clients overcome these challenges and successfully bring their products to market. From development to regulatory submission and ongoing compliance, we ensure adherence to EMA and ICH guidelines with tailored solutions for each client.

Partner with us for expert support throughout your product’s lifecycle.

Your trusted experts

With years of industry experience and a strong track record, QbD Group delivers innovative solutions that drive efficiency and solve complex challenges.

Full lifecycle support

From development to registration, authorization, and maintenance, we ensure your projects meet the highest quality standards and comply with EMA and ICH guidelines.

Tailored solutions

QbD Group offers customized, integrated solutions designed to fit your unique needs, maximizing efficiency and delivering impactful results.

Excellence at every stage

We follow quality-driven, GMP-compliant processes, ensuring seamless execution at every step while maintaining the highest industry standards.

Accelerate your entry into the European market

From regulatory strategy and GMP compliance to batch release and market authorization, QbD Group offers the full support you need.

Rely on our end-to-end expertise to make your entry into the European market smooth, compliant, and efficient.

Step 1: Research & Development

CRO support
Data management & statistics
Project & site management
Regulatory (CA, IRB/EC)
Safety & medical monitoring
Compliance & medical writing

Step 2: Regulatory Strategy & Submissions

Regulatory Affairs
RA strategy for pharma
Regulatory submission
CTD dossier compilation
Linguistic review
IMPD development & writing

Step 3: Manufacturing

Quality Assurance services
Audits & audit preparation
QMS implementation
eQMS solution: Scilife
Qualification & Validation
QC and Lab services

Step 4: Post-marketing

On-market support
Production support
QA support
Quality event management
Inspections & audits
Regulatory variations
Pharmacovigilance

Regulatory complexity & compliance

Stricter global regulations require full adherence to GMP, pharmacovigilance standards, and evolving guidelines placing continuous pressure on compliance teams.

Cost constraints & operational inefficiencies

Government price controls and reimbursement limitations often push companies to do more with less, exposing gaps in data management, asset tracking, and process efficiency.

Advanced research methodologies

The rise of complex therapies like biologics, cell and gene therapies calls for innovative development models and more agile, adaptive clinical trial designs.

Supply chain vulnerabilities & QA risks

Global sourcing, contamination threats, and the need for full batch traceability highlight growing quality assurance challenges throughout the supply chain.

Manufacturing innovation & optimization

The move toward continuous manufacturing and Process Analytical Technology (PAT) requires companies to rethink infrastructure, invest in new technologies, and optimize operations.

Our offerings for Pharma in

All

QPPV / Local Representative

Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide.

Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

Stay compliant with QbD Group's Literature Monitoring Services. Detect safety signals, ensure timely reporting, and enhance your vigilance strategy.

ICSR Management

Maintain compliance and protect patient safety with QbD's expert management of individual case safety reports (ICSRs). Simplify safety reporting processes for clinical...

Pharmacovigilance & Certified Blended Training

Empower your team with our certified pharmacovigilance training. Tailored courses to ensure compliance, mitigate risks, and enhance operational excellence.

Operational Software Compliance

Need seamless operational software compliance? QbD ensures your systems meet industry regulations, enhancing data security and reliability.

Digitalization

Our expertise in software implementation and IT partnerships ensures a seamless transition from traditional methods to advanced digital solutions, allowing you to...

AI/ML Compliance

Looking for guidance while developing software including AI-models? QbD offers AI/ML compliance support helping you be compliant with the latest standards and...

Data Governance

QbD Group offers data governance support, helping you comply with the latest regulations and shorten your path to market.

Software Validation, Central IT Systems

Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. We specialize in Computer System Validation (CSV) to...

Data Integrity

Ensure your data's accuracy and consistency with our tailored data integrity services. We provide expert guidance on complying with the latest regulatory standards,...

Software Implementations

Transform your life science organization with our expert software implementation services. Our team ensures seamless integration and compliance, delivering customized...

IT Infrastructure Qualification

Ensure your IT systems meet regulatory standards with our IT infrastructure qualification services. We specialize in validating on-premises and cloud-based systems to...

Paperless Validation

Transform your validation process with our Paperless Validation service, offering a digital, efficient, and error-free solution for regulated industries. Say goodbye to...

Commissioning

Commissioning is crucial for getting your systems and equipment to perform at their best and safest. QbD Group is the expert in making sure your systems, utilities,...

Facility Qualification

Confirm that your facilities and HVAC (heating, ventilation, and air conditioning), cleanrooms, and monitoring systems, meet predetermined specifications and regulatory...

Utility Qualification

Identify and mitigate risks associated with facility and utility failures such as water systems (WFI, ROW…), gas systems and distribution networks. Keep up to date with...

Equipment Qualification

Ensuring that machinery, instruments, or systems used in production, testing, or any other processes consistently perform as intended.

Process Validation

Our experts are pleased to set up, improve and support the validation of your processes.

Cleaning Validation

QbD Group can support you in the validation and qualification of your cleanrooms, making sure your equipment is truly squeaky clean.

Analytical Method Validation

QbD Qualification & Validation uses advanced tools and strict testing methods to ensure your analytical methods are accurate, precise, and reliable.

Sterilization Validation

Ensure that your sterilization processes meet the most stringent standards, ensuring the integrity of your products and safeguarding public health.

Tech Transfer

Tech Transfer is a vital process in translating innovation into real-world applications, driving economic growth, and fostering collaboration and innovation. Ensure a...

Process & Product Support

In today’s competitive marketplace, optimization of processes and products can make a real difference. Working with QbD Group, you can trust that your processes and...

QC Chemical Analysis

Our GP certified QC laboratory can support your analytical needs from pharmacopoeial analysis of raw materials, active pharmaceutical ingredients (APIs), and...

Method Development

Method development and validation are essential to the drug development process to ensure the methods are well-defined and fit-for-purpose, and the results are robust...

Method Validation

To ensure that the methods meet regulatory requirements, we follow relevant ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals...

Stability Studies

Investigating the stability and shelf-life of a finished product is an important area of expertise at QbD Group’s Lab Services. We can help you determine the best...

Cleaning Validation

Effective cleaning is essential to protect patient safety, and we can help you define a best practice approach in setting up plans and protocols for cleaning validation....

Microbiological Services

We can support you with routine testing and validation of the microbiological purity of raw materials and finished medicinal products. We have in-house, project-based...

Environmental Monitoring

We have invested in state-of-the-art equipment to perform active air sampling, as well as compressed gas sampling (air, nitrogen, argon, etc.) for microbiological...

QP Batch Release

Our Lab Services have authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC.Our own qualified persons (QPs) can certify...

Elemental Impurities

ICH Q3 described expectations regarding the control of elemental impurities in medicinal products or their excipients. Recently, authorities have been increasingly...

R&D Projects

QbD Group’s Lab Services is uniquely positioned to provide knowledge and customized solutions for the pharma industry.

Tracking Adverse Drug Reactions

Monitor and address adverse drug reactions with precision. QbD Group’s safety database solutions support regulatory compliance while prioritizing operational...

Vigilance and Pharmacoviglance Hotline Services

Emergencies don’t sleep and neither does our support. The One Vigilance hotline is open 24/7 all year round.

EudraVigilance Medicinal Product Dictionary (XEVMPD)

Achieve XEVMPD compliance effortlessly with QbD's expertise. Simplify your regulatory submissions and maintain up-to-date safety profiles for consistent, safe medicinal...

Aggregate Safety Reporting

Optimize your aggregate safety reporting with customized solutions from QbD. Manage risks, meet regulatory standards, and uphold patient safety with tailored strategies...

Project Management

Coordinate pharmacovigilance projects seamlessly with QbD’s project management expertise. Drive safety goals, meet compliance requirements, and improve operational...

Regulatory Intelligence

Stay ahead of evolving regulations with QbD’s regulatory intelligence services. Anticipate changes, address potential risks, and streamline compliance with informed,...

Strategic Planning

Align safety and business goals with QbD’s strategic planning services. Build a clear roadmap for compliance while maximizing value and operational efficiency for your...

Safety Signal Program

Enhance patient safety with QbD Group’s Safety Signal Program. Detect risks early, ensure compliance, and build trust with proactive safety solutions.

Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Streamline your pharmacovigilance compliance with QbD’s tailored QMS & PSMF services. Ensure efficiency, audit readiness, and global regulatory alignment.

Pharmacovigilance (PV) Audits

Ensure compliance & inspection readiness with QbD’s certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now.

QMS Implementation

Optimize your quality management system with QbD's tailored QMS Setup services. Build a smart, scalable system that aligns with regulatory standards and drives value.

QMS Remediation & Support

Achieve operational excellence with QbD's QMS Remediation & Support services. Address gaps, sustain certification, and maintain smooth operations seamlessly.

QA Outsourcing

Simplify compliance and reduce costs with QbD Group’s Outsourced QA solutions. Tailored support to manage your QMS or specific quality functions effectively.

Qualified Person (QP) & Responsible Person (RP)

Meet regulatory requirements with QbD Group’s QP/RP services. Rely on expert support for batch release, GMP/GDP compliance, and operational continuity.

Annual Product Review (APR) & Product Quality Review (PQR)

Streamline APR/PQR processes with QbD Group’s expert support. Ensure compliance, timely reviews, and actionable insights for product quality and safety.

QA Audits & Remediation

Audits are viewed as a necessity. We strive to see any audit as an opportunity to gain more insights into the company itself and the quality management system, which...

RA Strategy for Pharma

Bringing your pharmaceuticals to the market requires a tailor-made strategy. We can help you to form that strategy and make it a success.

Drug Development

New pharmaceuticals must be manufactured to high-quality standards before they can be placed on the market. We support you from drug discovery to pre-clinical and...

Early Development

We can maximize your success by leveraging our expertise in regulatory consultations and strategic planning for First-in-Human trials.

Scientific Advice

Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Our regulatory experts can help you to interact with the required...

Regulatory Procedures

There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. Our experts will lead you to the right...

Submissions

Irrespective of the type of your regulatory procedure your applications for marketing authorization must be accompanied correctly by the required documentation. Our...

eCTD Publishing

The skills needed to confidently compile electronic submissions can take years of training, industry immersion and regulatory study. Let us be your guide for electronic...

Artwork & Labeling

Artwork and labeling play an important role in the marketing process of any pharmaceutical and are highly regulated. Our regulatory experts will help you to create...

Lifecycle Management

Our experts will accompany you throughout the whole Product Life Cycle Management (PLM) process – from its conception, through design and manufacture, to service and...

Combination Products

Navigate the complex process of registering combination products in both the European Union (EU) and the United States (US).

Information Officer

A qualified Information Officer from QbD Group can coordinate and monitor pharmaceutical organizations’ information management and marketing activities.

Orphan Diseases

Rare diseases deserve just as much attention as more common diseases. We can support you in the development of medicines for patients suffering from rare diseases.

Regulatory Intelligence

Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times.

PDE-OEL Reports

We have a professional team of expert toxicologists to calculate the PDE value of any API and we offer the largest online library of high quality PDE reports available...

Nitrosamine Risk Assessment

Elaboration of comprehensive Nitrosamine Risk Assessment reports to ensure pharmaceutical product compliance with regulatory requirements regarding nitrosamine...

Organic Impurities Reports

We carry out toxicological evaluations of organic impurities according to ICH Q3A/B, assessing the toxicological risk and establishing a safety limit.

Extractables & Leachables Reports

Our extractables and leachables reports meet the highest quality standards. With rigorous scientific methodology and deep industry expertise, we help you ensure the...

Environmental Risk Assessment (ERA)

Assess the environmental profile of your pharmaceutical products with our detailed report. Identify, and mitigate the environmental risks associated with the life cycle...

Monitoring Studies

Keep up to date with standards and ensure the safety of your product. With more than 10 years providing Toxicology Services, membership to AETOX and certified by...

Clinical Trial Operations

Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.

Clinical Regulatory Services

We help sponsors and manufacturers who want to perform a study in Europe (and beyond) to navigate through the MDR requirements to make sure their study gets approved by...

Clinical Strategy Support

We can assist manufacturers by assembling a team of experts with diverse knowledge and backgrounds, such as physicians and clinical experts, to ensure all necessary...

Clinical Pharmacovigilance Service

Ensuring comprehensive safety oversight is essential in clinical trials. Our expertise in pharmacovigilance could offer invaluable support.

Data Management and Analysis

Clinical data management leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. The clinical data manager oversees the...

Clinical Quality Services

Looking for support in setting up your clinical Quality Management System (QMS), revision of Standard Operating Procedures (SOPs) or an audit? QbD Clinical is your...

Clinical Expert Services

Are you looking for research professionals to support your clinical study under your own management or in an FSP (functional service provider) model? Our expert team of...

Toxicology

QbD Group offers a set of Toxicology services, for your processes, applications, and equipment. We are EUROTOX certified and are members of AETOX.

Elemental Impurities Reports

Ensure compliance with elemental impurities regulations through QbD Group's expert risk assessments and tailored reports for pharmaceutical products, safeguarding safety...

Residual Solvents Reports

Ensure compliance and patient safety with QbD Group's residual solvent risk assessments, tailored to meet regulatory standards and quality requirements.

Linguistic Review

QbD Group offers expert linguistic review services to meet tight deadlines and regulatory requirements.

Landing in Europe

Accelerate your entry into the European life sciences market with QbD Group's expert regulatory support, compliance solutions, and strategic guidance for seamless...

Why QbD Group?

At QbD Group, we provide deep expertise to guide pharmaceutical companies through complex regulatory landscapes and ensure compliance throughout the product lifecycle.

Our team understands the stringent requirements needed to safely and effectively develop, approve, and distribute pharmaceutical products.

Beyond market entry, we continue supporting businesses by managing critical processes that ensure the ongoing safety, efficacy, and compliance of their products before and after they reach patients.

Get in touch

+10 years of experience

Full lifecycle support

Global presence

Best managed company

Get in touch

Get in touch with our experts today and discover how QbD Group can support your small molecule and generics projects. Fill out the form, and we’ll respond promptly to help bring your products to market efficiently and compliantly.

Discover our expertise in other industries

Beyond Pharma, QbD Group is a trusted partner in Medical Devices and In Vitro Diagnostics. Explore how our tailored solutions drive innovation and compliance in these specialized fields.

Medical Devices

Pharma & Biotech

Your trusted experts

Full lifecycle support

Tailored solutions

Excellence at every stage

Accelerate your entry into the European market

Your pharma journey, step by step

Step 1: Research & Development

Step 2: Regulatory Strategy & Submissions

Step 3: Manufacturing

Step 4: Post-marketing

Industry challenges

Regulatory complexity & compliance

Regulatory complexity & compliance

Cost constraints & operational inefficiencies

Cost constraints & operational inefficiencies

Advanced research methodologies

Advanced research methodologies

Supply chain vulnerabilities & QA risks

Supply chain vulnerabilities & QA risks

Manufacturing innovation & optimization

Manufacturing innovation & optimization

Our offerings for Pharma in

QPPV / Local Representative

Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

ICSR Management

Pharmacovigilance & Certified Blended Training

Operational Software Compliance

Digitalization

AI/ML Compliance

Data Governance

Software Validation, Central IT Systems

Data Integrity

Software Implementations

IT Infrastructure Qualification

Paperless Validation

Commissioning

Facility Qualification

Utility Qualification

Equipment Qualification

Process Validation

Cleaning Validation

Analytical Method Validation

Sterilization Validation

Tech Transfer

Process & Product Support

QC Chemical Analysis

Method Development

Method Validation

Stability Studies

Cleaning Validation

Microbiological Services

Environmental Monitoring

QP Batch Release

Elemental Impurities

R&D Projects

Tracking Adverse Drug Reactions

Vigilance and Pharmacoviglance Hotline Services

EudraVigilance Medicinal Product Dictionary (XEVMPD)

Aggregate Safety Reporting

Project Management

Regulatory Intelligence

Strategic Planning

Safety Signal Program

Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Pharmacovigilance (PV) Audits

QMS Implementation

QMS Remediation & Support

QA Outsourcing

Qualified Person (QP) & Responsible Person (RP)

Annual Product Review (APR) & Product Quality Review (PQR)

QA Audits & Remediation

RA Strategy for Pharma

Drug Development

Early Development

Scientific Advice

Regulatory Procedures

Submissions

eCTD Publishing

Artwork & Labeling