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Regulatory CMC Strategy and Intelligence

We provide strategic advice and planning of regulatory CMC submissions at both pre- and post- marketing phases based on global regulatory requirements. We can provide Regulatory CMC intelligence by summarizing, interpreting and assessing regulatory requirements to ensure submissions are current and compliant. Robust strategies based on regulatory intelligence can help during development and post-marketing activities ensuring successful submission reviews and on-time market launch.

CMC Regulatory Gap Analysis

We conduct procedural and submissions reviews to identify gaps and inconsistencies. We perform assessments in light with global regulatory requirements (FDA, EMEA, Health Canada, TGA among others) so sponsors can feel confident about their submissions.

Conformance and Compliance

Due to constantly changing regulations, compliance can be somewhat challenging. However, lack of compliance can be even more costly and reputation damaging. We work with manufacturers and sponsors to fulfill any CMC-specific commitments made with the Health Authorities and help establish CMC conformance as a key element to maintain CMC compliance.

CMC product portfolio management

We can manage a sponsor’s CMC product portfolio either in part or in full through a product’s entire lifecycle. We assist sponsors and manufacturers in managing: 1. Their change control process 2. All CMC activities (annual reports, health authority queries, variations, customer inquiries etc.) submissions process 3. Product teams through CMC guidance consulting

CMC Change Management

We can provide execution strategies and manage changes from beginning to implementation for all types of CMC changes. Managing changes both at investigational and post-approval phases is critical since regulatory agencies’ quality and compliance initiatives are getting stronger. We can work with your quality team to design change control processes through the lifecycle of a product.

Authoring Services

We can help prepare CMC (Module 2 QOS and Module 3) dossiers for: 1. Marketing applications (ANDA/NDA/MAA) 2. Post-approval maintenance (Variations/Supplements, Annual reports) 3. Pre-approval phase appropriate IND and IMPD 4. Briefing books for meetings FDA meetings and Scientific Advice Briefing document 5. Type II Drug Master Files (DMF) 6. Responses to CMC Agency inquiries 7. CMC Regulatory SOPs

Training Services

We offer a range of customizable industry training services for companies with case studies in small groups. We facilitate training and train-the-trainers sessions for clients and can help you cut costs on routine training needs.