Regulatory Compliance
TK-CHAIN® supports its clients with regulatory compliance across the entire product lifecycle from pre- through post-approval for the U.S. Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA).
Development
- FDA Regulatory Strategy and Gap
- Analysis FDA Meeting Strategy and Execution -FDA Regulatory Submission Process and Guidance
- Chemistry, Manufacturing, and Controls (CMC) Advice and Management
- Clinical Pharmacokinetics (PK)/Pharmacodynamics (PD)
- Regulatory Due Diligence
- Pre-Approval Audits
- Specialized Regulatory Consulting Services
- Medical Device FDA Meetings
- Medical Device FDA Submissions
Clinical
- FDA Regulatory Strategy and Gap Analysis
- FDA Meeting Strategy and Execution
- FDA Regulatory Submission Process and Guidance
- Chemistry, Manufacturing, and Controls (CMC) Advice and Management Clinical
- Pharmacokinetics (PK)/Pharmacodynamics (PD)
- Clinical Trial Applications (CTAs)
- Medical/Technical Writing
- Medical Device FDA Meetings
- Medical Device FDA Submissions
Commercial
- FDA Meeting Strategy and Execution
- FDA Regulatory Submission Process and Guidance FDA
- Medical Device Development
- EU Medical Device Development Product Lifecycle Management
- Product Launch
- Regulatory Project Management
- Regulatory Intelligence (RI)
- Promotional Material
Figure 2 TK-CHAIN® Regulatory Services
Below is a description of some of the company regulatory affairs solutions at different stages of the drug development pipeline.
FDA Regulatory Strategy and Gap Analysis
TK-CHAIN® Life will work with the client to develop an appropriate and effective strategy to get their product to market. Combining knowledge of the client’s product with years of experience (including pre-clinical, clinical, chemistry, manufacturing, and controls (CMC), drug safety, and pharmacokinetics). literature research and similar approvals, the company will come up with a regulatory strategy that balance srisk, speed to approval, and cost. Clients are also provided with a description of the most appropriate regulatory path and an explanation of why this path is the rational choice. Related services the company will offer include:
FDA Meeting Strategy and Execution
It is important that in order to prepare for a meeting with the Food and Drug Administration (FDA), the client has answers to critical questions and an understanding of the FDA’s expectations. The interaction must be carefully planned and flawlessly executed, leaving the FDA with a good impression of client’s product and company. Leveraging it experience, knowledge of science, medicine, ethics, and regulations TK-CHAIN® can act as an advocates for the client before the FDA, guiding them step-by-step through the FDA meetings during each phase of the development process, including:
- The pre-IND meeting planning
- End of Phase 2 (EOP2) Guidance
- Pre-NDA Meeting Guidance
- FDA Advisory Committee Meeting Guidance
FDA Regulatory Submission Process and Guidance
Through this service, the company offers expert guidance and regulatory submission support throughout the entire submission process. TK-CHAIN® leverages its extensive experience and knowledge of FDA processes to ensure a seamless submission process. Key areas the company provides FDA regulatory submissions are:
- Investigational New Drug (IND) Submission Guidance
- New Drug Application (NDA) Submission Guidance
- Abbreviated New Drug Application (ANDA) Submission Guidance
- Orphan Drug Designation (ODD) Submission Guidance
Nonclinical Drug Development
TK-CHAIN® assists in developing a sound nonclinical development program can to ensure that time and resources are not spent on studies that fail to address the issues of concern to regulatory authorities, and thus may need to be repeated.
TK Chain’s nonclinical consultants will help maximize a Sponsor’s potential for success by designing pharmacology, pharmacokinetics, and toxicology programs that are appropriate to support the intended indication, route of administration, and duration of treatment for the product. In addition, the company can provide the following operational toxicology support:
- Nonclinical Study Design, Placement, and Monitoring
- Discovery Stage Assistance
- Nonclinical Results Analysis and Design of Follow-On Work
Chemistry, Manufacturing, and Controls (CMC) Advice and Management
TK-CHAIN® leverages its experience in regulatory strategy and CMC development to help the client appropriately analyze and document the manufacturing processes, active substance and drug product characteristics, and testing to ensure the product is safe, effective, and consistent.
From early-stage development and at every point through commercialization, TK-CHAIN® works with clients to tackle complex CMC challenges, ensuring the regulatory authorities see the control and robustness of the client’s process and product from a documentational and operational perspective.
Clinical Pharmacokinetics (PK)/Pharmacodynamics (PD)
A key requirement of the FDA, TK-CHAIN® helps clients develop a comprehensive PK/PD program. Leveraging its resource pool, it helps the client analyze, interpret, and apply the right data to prove that the product is safe and effective.
Regulatory Due Diligence
TK-CHAIN® helps the client perform all the necessary regulatory due diligence to help it make major strategic decision e.g corporate pharmaceutical acquisition, or the acquisition of an asset such as a product, corporate division, or an entire company. After the company’s team of experts has analyzed all available information and performed a rigorous pharmaceutical due diligence review, it will will report all its findings and recommendations in a report to the client.