Our Services
Global Regulatory Chemistry Manufacturing and Control (CMC) support through cross-functional interactions with client's manufacturing, clinical and therapeutic area teams. We are working with any type of biologics, including biotechnology products, monoclonal antibodies, bispecific antibodies and fusion proteins, ADCs, vaccines, cell and gene therapies, mRNA-based technologies and any new therapeutic modalities.
- Regulatory Gap Analysis: Assess current documentation and processes against regulatory requirements to identify gaps.
- Regulatory Strategic Planning: Develop detailed regulatory roadmaps for product development and submission.
- Strategic Planning: Develop long-term CMC regulatory strategies tailored to specific markets and product types.
- Agency Meetings: Prepare for and facilitate meetings with regulatory agencies (FDA, EMA) to discuss CMC-related issues, authoring of regulatory submissions (Module 3): Pre-IND packages, INDs, IMPDs, pre-BLA packages.
- Ad Hoc Consulting: Provide expert advice on specific CMC issues as they arise.
- Regulatory Intelligence: Monitor and analyze changes in global regulatory requirements and provide strategic guidance.
- Regulatory Project Management (RPM) and CMC Dossier Preparation: We can customize and provide a wide range of Regulatory templates, such as Regulatory eCTD Submission Trackers for the compilation of dossiers, such as IND or BLA focused on specific types of biological therapeutic modalities. Our in-house established Regulatory workflows and templates are based on most current US FDA, ICH and EMA guidance documents.
- Authoring, Compilation and Review of CMC sections (Module 2, QOS and Module 3) of regulatory submissions (IND, NDA, BLA, MAA).
- Authoring of Technical Reports: Write and review technical reports, including validation reports, stability studies, and manufacturing process descriptions.
- Module 2, QOS and Module 3 Preparation: Prepare the Quality section (Module 3) of the Common Technical Document (CTD).
- Pre-IND, pre-BLA, type D and Type C FDA CMC meetings, Comparability Proposals (clinical stage) and Comparability Protocols (commercial stage), Scientific Advise and other types of FDA and EMA meetings.
- Post-Approval Changes: Manage regulatory submissions for post-approval changes, including CMC variations, supplements, and amendments.
- Regulatory Compliance Monitoring: Monitor ongoing compliance with regulatory requirements and guidance updates.
A patent is a right granted to the owner of an invention that prevents others from making, using, importing or selling the invention without her permission. Our team has expertise in protecting inventions in the United States. We provide the following services:
- U.S. patent drafting, filing and prosecution
- Prior art searches
- Intellectual Property counseling and strategic management
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