-
Product Development
-
Clinical Trials
-
Quality
-
GxP Audits
-
Regulatory Affairs
-
Pre-authorisation
- Regulatory Roadmap
- Scientific Advice
-
Product information
-
Dossier preparation
- Dossier Gap Analysis
- MA Handling
- Post-authorisation
- Regulatory outsourcing
-
Pre-authorisation
-
Pharmacovigilance
-
QP Service / Importer
Quality Data in Registration Dossier (Module 3) Preparation for Medicinal Products
Comprehensive Support from SciencePharma
Preparing the quality part (Module 3) of the Common Technical Document (CTD) is one of the most complex and critical steps in the process of obtaining a Marketing Authorisation (MA) for a medicinal product. This section provides detailed pharmaceutical and chemical data that must meet stringent regulatory requirements and scientific standards.
The extensive and often overlapping regulatory requirements for medicinal products can be challenging to navigate. At SciencePharma, we offer expert support in the preparation, evaluation, and optimisation of Module 3 to gather relevant information and present it in a clear, well-organised manner to ensure the highest possible standards of product quality and safety across Europe and beyond.
What do we do?
At SciencePharma, we support companies in preparing Module 3 of the CTD dossier, ensuring it meets both scientific rigour and regulatory expectations across various European markets. We provide end-to-end support in compiling, reviewing, or auditing Module 3 documentation, tailored to the specific type of product and its intended regulatory pathway (national, DCP, MRP, or centralised procedure). Our services include:
- Full or partial preparation of Module 3 documentation
- For chemical, herbal, biological, and biotechnological products.
- Gap analysis and dossier auditing
- To identify missing, inconsistent, or excessive data that may trigger regulatory questions or delays.
- Preparation or revision of Module 3 sections, including:
- 3.2.S – Active Substance (based on ASMF, CEP or full data),
- 3.2.P – Finished Product (formulation, development, manufacturing, control, stability),
- 3.2.A, 3.2.R and 3.3 – Appendices, regional information, literature.
- Design and verification of pharmaceutical development strategies
- Aligned with dosage form, administration route, patient population, and product lifecycle goals.
- Verification of compliance with current EMA guidelines, European Pharmacopoeia, and Notice to Applicants recommendations.
- Guidance on risk assessments
- Including nitrosamine evaluation and impurity profiling.
- Review of third-party documentation (e.g., when acquiring dossiers) for regulatory adequacy.
- Scientific justification drafting (e.g. choice of manufacturing process, use of preservatives, packaging system, or impurity limits).
- Support during responses to regulatory authority questions on the quality part, including strategy and wording.
At SciencePharma, we bring together a team of seasoned experts with extensive hands-on experience. Staying up to date with changing regulatory guidelines is a top priority for us.
We have reviewed and worked on hundreds of registration dossiers across a wide range of procedures and countries, covering all product types – from tablets and syrups to parenteral formulations, and from small-molecule drugs to biological and advanced therapy medicinal products (ATMPs). We have successfully registered numerous products worldwide and have navigated a variety of regulatory challenges that can arise during dossier evaluation.
We know how to avoid mistakes and prepare reliable documentation that complies with current regulations, meets the expectations of Compatent Authorities, and passes the assessment process smoothly and without complications. Our experts possess the knowledge and expertise to assess whether a given quality dossier meets the requirements for EU procedures at both national and international levels – including the Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and the Centralised Procedure.
Ensure your product meets the highest quality standards – partner with SciencePharma
With a team of experts combining strong scientific backgrounds, in-depth knowledge of current regulatory guidelines, and an innovative, out-of-the-box approach, we are well-equipped to thoroughly assess the quality of your medicinal product helping to ensure a smoother and more efficient registration process.
Contact us today to discuss how we can support your dossier preparation or assess your existing Module 3 documentation. Let’s make your next submission smooth, compliant, and successful.
Get in touch now – and be ready for the next step in your product’s journey to the market.