A Comprehensive Guide to Drug Development Consulting

1. A Comprehensive Guide to Drug Development Consulting (DDC) are a full-service global product development and strategic regulatory group providing end-to-end lab-to-launch program drug development consulting services, including regulatory strategy and operations, CMC and product/analytical consulting, clinical oversight, toxicology, and other non-clinical consulting services, quality/GMP consulting, electronic submissions? We have a proven track record of successful FDA negotiations and approvals. Our teams have the expertise to support your projects throughout their lifecycle, from preclinical development to approval and post-marketing. We serve the biotechnology, pharmaceutical, and device industries worldwide. Our professional staff has experience across a wide range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, devices, and combination products in all phases of program development (Phase I - IV) and commercialization.

2. The Basic Principle ● Our work is based on the following elementary principles: ● As a development partner, we assist companies in strategically developing new pharmaceutical and biotechnology products. ● We strive to create an environment for learning and professional development. ● We support team building on projects and programs to advance our client's goals better and foster long-term employee development for our clients and employees. ● A Drug Development Consulting team is unique in that it uses the concept of a team beyond its employees. For example, we bring experts from different fields together and collaborate with our global partners to achieve maximum productivity. Most importantly, our team members are integrated into the client's program and become part of the client's team to ensure program success. Our team model fully understands your program needs, providing the right expertise, redundancy of knowledge, cost reduction, and highly effective results. We strive for perfection in every project and to achieve our client's goals.

3. Drug Development Strategy Our experts can help you understand new and existing guidelines to ensure that the medicinal product meets all regulatory guidelines and support the drug development services from the early stage to the submission of marketing authorization. Also, define effective regulatory strategies in line with company and regulatory requirements to facilitate post-approval activities. Submissions can be prepared or reviewed for deficiencies along with a thorough deficiency analysis and risk assessment before submission to ensure that any questions that may arise from health authorities are anticipated and can be answered. Assist with quality control, publication of regulatory submissions, and preparation for agency meetings.

4. Our Holistic Approach ● Our drug development consultants work with you to design and implement a successful drug development program. ● With cutting-edge scientific expertise across various technical disciplines, we assist customers at all stages of development, from candidate selection to commercial launch. ● Our consultants have a proven track record of cutting across industry forces to reduce development time and cost. With hands-on development experience across hundreds of drug discovery of new molecules and product types, we help you avoid critical pitfalls, manage risk and maximize the potential for success.

5. Timing and Scope of Clinical Advice in Drug Development It is ideal to start consultation with drug development consultants when non-clinical studies are underway or earlier. Drug development plans should be based on the mechanism of action and should rely on data from non-clinical efficacy and safety studies. It is common for projects to need to return to the non-clinical phase after reaching clinical trials due to a lack of relevant data. Gap analyses for non-clinical data should serve as a starting point for clinical development plans concerning the new drug's intended indication and expected application (NDA). The entire development timeline may be jeopardized if gaps in the mechanism of action and non-clinical data are identified when clinical trials are initiated. However, the points for successful clinical biostatistics consulting are considerably broader than the clinical trial plan. Items for consultation include full-scale unmet medical need analysis and scope of development based on mechanisms of action, clinical development plan, IND strategy, regulatory communications, zoning, investigator brochure development, target product profile creation and update, companion diagnostics development, clinical trial design, outsourcing, and vendor management strategies, scientific advisory board leadership, and publication strategy.