Pharma & Biotech

Is your company looking for support within the development process of (complex) generics?

QbD Group can be your partner in the development and production of your pharmaceuticals.

Specialized in complex generics

QbD Group excels in developing complex generics, ensuring compliance with EMA and ICH guidelines for a smooth market entry.

Full regulatory lifecycle support

We handle the entire regulatory life cycle, from initial approvals to ongoing variations, ensuring continuous market compliance.

Expert CMC management

Our team ensures your Chemistry-Manufacturing-Control (CMC) dossiers meet regulatory expectations for quicker approvals.

End-to-end development support

QbD Group partners with you throughout the development process, from planning to product launch, ensuring success at every stage.

Our offerings for Pharma in

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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.

Digitalization

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

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...

Operational Software Compliance

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

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.

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...

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.

Certified PV Audits, Mock Inspections & Activities ISO

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

QPPV / Local Representative

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

Pharmacovigilance & Certified Blended Training

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

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.

QMS Setup

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.

Outsourced QA

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.

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 Study Operations

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

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 Pharmacovigilance Service

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

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 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...

Medical Writing for Medical Devices

Our expert team of knowledgeable writers will be happy to develop the right document for your needs, from the early phases to post-approval.

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 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.

Analytical-method-validation-and-development-Services-QbD-Oct-01-2024-03-02-19-8198-PM

Industry challenges

In an era of rising costs, increased focus on global developments and manufacturing operations, pharmaceutical manufacturing demands detailed planning and a deep understanding of the regulatory, quality, and clinical aspects to bring these drugs to the market.

The regulatory life cycle of small molecule marketing authorizations can be resource intensive. Once the registration is obtained multiple variations are expected on annual basis. A sound understanding of the applicable scientific and regulatory EMA and ICH guidelines for the development of small molecule-based medicinal products is required to reduce the time-to-market.

Product development of new generic molecules starts early in the life cycle of the originator product (at the time of market launch), so long-term planning is essential. While small-molecule generics can be straightforward, complex generics require specialized expertise.

QbD Group can support pharmaceutical developers with full life cycle management for your marketing authorizations, such as ensuring that the CMC (Chemistry-Manufacturing-Control) section of the registration dossier (CTD Module 3) conforms with regulatory expectations.

Why QbD Group?

EXPERTS IN LIFE SCIENCES

The QbD Group Regulatory Affairs team has the experience to guide manufacturers of small molecules and generics through the product development regulatory requirements and to generate a full registration dossier ready for submission to the competent authorities.

We can also support you in the actual registration process from the submission of a marketing authorization (MA) application until the MA is granted for generic and hybrid drug applications.

Don't hesitate to contact us.

+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.

Case studies

Case study

Ensuring pharmaceutical production quality: cleaning validation for government agency

Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.

Case study

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Helping KU Leuven advance glioblastoma research to the clinic with strategic business planning, funding support, and a roadmap for clinical impact.

Case study

Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.

Case study

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

QbD Group has facilitated the launch of a new drug production line for treating hemophilia, overseeing the qualification of over 100 pieces of small-scale supporting equipment.

Discover all

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