Product Development Consulting
Empowering pharmaceutical excellence through CMC strategy, program management, and regulatory expertise
Ensuring compliance, optimizing development pathways
Elevate your biopharmaceutical product development projects with our diverse industry expertise and experience. From your pre-clinical to late-stage clinical development, our seasoned team can guide your program.
We create development strategies in line with your budget and timing expectations.
We apply best practices and phase-appropriate development approaches using experienced consultants and deliver on the selected strategy.
Our experts ensure compliance with all GxP requirements and keep updated on dynamic regulatory guidelines and industry trends. In addition, we can provide a broad range of compliance services, including phase-appropriate QMS development, QA lot release, and QP services for your clinical trial needs.
You can trust our team to support your wide range of needs in drug substance and drug product development programs.
Our services
Drug Substance Services
Drug Product Services
Quality Assurance and Qualified Person Services
Regulatory Affairs
Expert guidance – PLG strategic approach to product development consulting
You gain a competitive edge in the pharmaceutical landscape by choosing us for product development consulting. Our expertise spans the entire product development lifecycle, from early-stage drug substance development to late-stage drug product optimization and regulatory compliance. This translates into streamlined operations, accelerated market entry, and substantial cost savings. We prioritize quality assurance and regulatory compliance, ensuring your product meets phase-appropriate standards and safety requirements. With PLG as your partner, you access a wealth of knowledge and experience, positioning your pharmaceutical endeavors for success in a complex and dynamic industry.
- We have a dedicated team of CMC and quality experts with an average experience of over 20 years each in the biopharmaceutical industry.
- With over 500 completed projects in CMC and quality, we have the expertise to navigate agencies’ regulations and ensure compliance.
- Our tailored solutions include CMC HealthChek™ – Program Gap Analysis, designed to meet your needs and accelerate your time to market.
- We have an in-depth understanding of regulatory requirements for all the major regions and could cover a wide range of pharmaceutical forms across multiple therapeutic areas.
Case Study: Accelerating success in Phase 2 pharmaceutical development with product development consulting
Client profile:
A Phase 2 pharmaceutical company specializing in novel small molecule drug candidates for oncology and rare diseases, aiming to expedite product development while ensuring regulatory compliance and product quality
Challenges:
- Streamlined development: The client needed to streamline their drug substance and drug product development processes to efficiently progress through Phase 2 clinical trials.
- Regulatory compliance: Ensuring compliance with evolving regulatory requirements, including cGMP, during scale-up and manufacturing
- Quality assurance: Maintaining stringent quality standards for clinical supplies and facilitating a smooth transition to commercial manufacturing
Solution:
The client engaged with PLG for our comprehensive product development consulting. Our team of experts collaborated closely with the client throughout the project.
Key Services Provided:
- Early and late-stage development support: Our experts guided the client through early-stage drug substance development, ensuring efficient synthesis and purification processes. We fine-tuned formulation and manufacturing processes for late-stage optimization to meet clinical demands.
- Regulatory affairs excellence: Our regulatory affairs specialists navigated complex regulatory landscapes, ensuring all documentation met regulatory requirements and milestones were achieved promptly.
- Quality assurance and compliance: We implemented stringent quality control measures, guaranteeing product quality and compliance with cGMP throughout development. Our team also managed stability studies and supported batch releases.
- Supply chain management: PLG orchestrated a seamless supply chain for clinical materials, ensuring a reliable and timely flow of investigational products to clinical trial sites.
Results:
- The client’s Phase 2 trials progressed smoothly with a shortened timeline, saving time and resources.
- Regulatory milestones were met without delays or complications, positioning the product for successful submissions.
- Quality assurance measures maintained the highest standards, facilitating the transition to commercial manufacturing.
- Overall, the client achieved a streamlined and efficient Phase 2 development process, poised for successful Phase 3 trials and future commercialization.
Conclusion:
PLG’s product development consulting provided invaluable support for the client’s Phase 2 pharmaceutical development, ensuring efficient progress, regulatory compliance, and top-tier product quality. With the foundation in Phase 2, the client is well-prepared for the following stages of clinical development and eventual market entry.
Case Study: Achieving BLA Success with Comprehensive Product Development Consulting
Client profile:
A Phase 3 biopharmaceutical company specializing in the development of a groundbreaking biologic therapy for a rare autoimmune disease to file a Biologics License Application (BLA) and achieve regulatory approval
Challenges:
- Complex biologic development: The client’s biologic product posed complex manufacturing and quality challenges, requiring expertise in process development and regulatory compliance.
- BLA preparation: The client needed meticulous preparation and submission of the BLA to meet stringent regulatory requirements.
- Quality assurance excellence: Maintaining rigorous quality assurance standards, including cGMP, throughout the product lifecycle
Solution:
The client engaged with PLG to benefit from our comprehensive product development consulting, which leverages the expertise of our multidisciplinary team.
Key Services Provided:
- End-to-end CMC support: Our experts assisted the client in optimizing the bioprocess from early-stage development through Phase 3, ensuring scalability and reproducibility: this involved process development, scale-up, and tech transfer for manufacturing.
- Regulatory affairs mastery: Our regulatory affairs specialists navigated the intricate regulatory landscape, meticulously preparing the BLA dossier and ensuring compliance with FDA requirements. This included authoring, reviewing, and submitting CMC documentation.
- Quality assurance and compliance: We implemented stringent quality control measures, conducted risk assessments, and established a robust quality management system (QMS). We also supported the client in conducting validation studies and stability programs to meet cGMP standards.
- Supply chain management: To guarantee a seamless supply chain for clinical materials and future commercial production, we managed logistics, vendor selection, and oversight.
Results:
- The client successfully filed a comprehensive BLA with the FDA, meeting all regulatory milestones and requirements.
- Regulatory hurdles were expertly navigated, positioning the product for a timely review and potential approval.
- Stringent quality assurance measures ensured that product quality remained uncompromised, setting the stage for commercialization.
Conclusion:
PLG’s product development consulting was pivotal in the Phase 3 biopharmaceutical company’s journey toward BLA filing and potential regulatory approval. With a strong foundation in bioprocess development, regulatory compliance, and quality assurance, the client is well-positioned to advance its innovative therapy to market and offer a promising treatment option for patients with a rare autoimmune disease.