Regulatory & Consulting Services

Our dedicated CMC and clinical experts are ready to provide the following services with respect to the biologic drugs and vaccines:

• Preparation of regulatory and development strategy for EU and US markets, including Scientific Advice meetings with EMA/EU regulators and meetings with the FDA
• Scientific and regulatory support in process development, manufacturing, quality control, pre-clinical and clinical research
• Medical and regulatory writing (including full product dossier)
• Performing regulatory submissions and handling interactions with drug agencies (EMA, FDA and national authorities)

Preparation of regulatory and development strategy for EU and US markets

Designing optimal regulatory pathway from the very early stages of development is key to ensuring compliance and achieving successful drug approval. Mabion has a thorough understanding of this concept and pays huge attention to preparing the development plan that would satisfy the requirements of all relevant authorities. Our specialists can offer:

• Preparing drug development strategy satisfying EMA and FDA requirements;
• Planning, preparing and leading the meetings with regulatory agencies (including Scientific Advice meetings, Oral Explanations at EMA as well as BPD Type I-III and pre-IND meetings at FDA);
• Benchmarking and market analysis;
• Reviewing and performing gap analysis of the existing CMC, pre-clinical and clinical data/documentation;
• Providing scientific and regulatory support to all teams participating in the biologic drug development;
• Developing Target Product Profile;
• Planning the conduct of pre-clinical and clinical studies to meet regulatory requirements and business needs;
• Tailoring the clinical development program to address the issues emerging from pre-clinical studies;
• Designing pre-clinical and phase I-IV clinical studies (protocol writing)

Scientific and regulatory support in process development, manufacturing, quality control, pre-clinical and clinical research

Being continuously up-to-date with the requirements of EU and US drug agencies and having a broad overview of the entire development process, our expert team can quickly identify and resolve any issue that may be encountered on the pathway to drug commercialization.
Mabion team is ready to perform the following tasks:

• Defining regulatory requirements for process development and transfers, in terms of manufacturing and quality control;
• Defining the content of analytical and quality control package required for clinical trials and MAA submission;
• Performing gap analyses within the drug manufacturing and quality control process;
• Supporting the development, qualification and validation of analytical methods;
• Supporting scale down models development and qualification;
• Supporting manufacturing process development from lab scale to full scale and the validation of the final process as well as process transfers;
• Preparing regulatory documentation related to drug manufacturing and quality control;
• Supporting contract manufacturing of biologic drugs and vaccine components for research and commercial purposes;
• Performing audits of manufacturing sites and bioanalytical laboratories;
• Review and analysis of clinical trial data to optimize regulatory approach and facilitate drug approval.

Medical and regulatory writing (including full product dossier)

Appropriate structure and wording of regulatory dossier can be as important as the quality of data supporting the application. Our skilled writers are capable of bringing together different pieces of evidence from different non-clinical and clinical areas to produce high-quality regulatory documentation.
Mabion’s medical and regulatory writing services include:

• Writing and/or reviewing the reports from pre-clinical pharmacology and toxicology studies;
• Preparing and reviewing the clinical study documentation from the study inception to regulatory filing (protocol, SAP, ICF, IMPD/IB and CSR);
• Preparing all documentation required for the regulatory dossier;
• Preparing documentation for regulatory meetings with EMA and FDA: developing questions, company’s positions and background materials;
• Reviewing and submitting regulatory documentation (including meeting requests, meeting packages and briefing documents);
• Writing and managing the responses to health authorities;
• Performing regulatory gap analysis and risk management;
• Preparing the Orphan Drug Designations requests (ODDs)

Performing regulatory submissions and handling interactions with drug agencies (EMA, FDA and national authorities)

We build positive relationship with drug agencies to better understand their requirements and expectations, and then implement this knowledge into the ongoing drug development.

Mabion team can assist your company in:

• Planning, managing and compiling the regulatory dossier in compliance with eCTD format;
• Interpreting and implementing the latest regulatory guidances;
• Preparing for and leading the meetings with regulatory agencies;
• Submitting dossier and other regulatory documents to the EMA, FDA and national authorities;
• Managing communication with EMA, FDA and national authorities on an everyday and/or project-specific basis.

It doesn’t matter if your business has just started pre-clinical research or is finalizing the regulatory dossier, the Mabion team can take it from there and seamlessly guide you to the successful drug approval.