Enormous changes are occurring within the world of pharmaceuticals. Competition is intensifying, regulations are becoming stricter, and innovations must be delivered on budget at an increased pace than ever before. Given these factors, pharmaceutical companies can no longer rely entirely on their internal business processes. Strategic outsourcing and leveraging active strategic partnerships, and seeking out experienced regulatory consultants, have become critical to growing successfully and minimizing risk.
In the biopharma arena today, many consider two necessary partners to be:
- Contract Manufacturing Consultants: These individuals specialize in assisting biotech and pharma companies through the vendor selection process, technology transfer, regulatory compliance, overseeing proper quality control, and optimizing the manufacturing process; and
- Comparator Drug & Pharma Licensing Services Providers: These organizations specialize in assisting pharmaceutical companies to source comparator drugs for use in clinical trials and also provide the appropriate permits and licenses for use. They provide support with navigating the increasingly complex global licensing framework.
These two services represent the foundation of drug development and speed to market today. The article below will outline how these two functions allow pharmaceutical companies to scale up more effectively, reduce operating costs, avoid regulatory challenges, and ultimately get higher-quality products into the marketplace more rapidly than ever before.
The Changing Pharma Manufacturing Landscape
The medical industry can no longer rely on traditional ways of working where a single business completes all R&D, manufacturing, packaging, and distribution functions internally. The industry has become much more collaborative and diverse. In fact, contract manufacturers, specialist laboratories, and third-party regulatory agencies now provide support for each step of the supply chain process.
The transition to this more collaborative approach has also created many opportunities for new and existing biotech companies, as well as large established pharmaceutical companies:
- Less expensive capital expenditures
- Reduced development timelines
- Greater global manufacturing capacity
- Better understanding and access to cell/gene therapy or biologics technologies
- Finer risk mitigation.
Despite these opportunities, the rapidly changing nature of the outsourced environment presents its own set of challenges. A poorly chosen manufacturing partner, mishandled regulatory paperwork, or not being able to source comparator drugs can prevent projects from completing. Contract manufacturing consultants will help with these obstacles.
What Exactly Does a Contract Manufacturing Consultant Do?
A consultant for contract manufacturing provides more than just a service; they serve as an extension of your internal team—acting as a project manager, strategy expert, compliance officer, and risk manager.
Roles of a Contract Manufacturing Consultant
A. CMO/CRO Identification and Qualification
Each contract manufacturer (CMO or CRO) has different specialities based on their facilities’ strengths and weaknesses. A consultant will help you find the appropriate contract manufacturer based on:
- Type of Dosage Form
- Capacity Needs
- Regulatory History
- Cost Model for Manufacturing
- Desired Timeline
- Experience in Relevant Therapeutic Category
Once the appropriate contract manufacturers have been identified, the consultant conducts a review (e.g. site assessments, negotiations), and once there is alignment for all parties involved, the consultant will help ensure that contract manufacturing is aligned with the client’s strategic goals.
B. Technology Transfer Management
The process of transferring your drug formulation or manufacturing process to a new contract manufacturer is one of the most challenging aspects of drug development. Mistakes made during this process can be very expensive and result in long delays. The consultant’s role is to manage all documentation associated with the technology transfer as well as to maintain communication and support all validation activities during the transition.
C. Compliance & Quality Oversight
Ensuring compliance is key for everything from GMP audits through to the quality agreement with your clients. A consultant reviews:
- Complete and accurate documentation
- Facilities compliant with global authorities, including the FDA, EMA and WHO
- Risk assessments have been completed
- Deviation and CAPA management are appropriate
D. Cost Optimization & Contract Negotiation
Manufacturing contracts are not only expensive, but also complex. Consultants negotiate favourable terms while ensuring that corners are not cut.
E. Complete Supply Chain Support
The management of raw materials, packaging components, testing labs and logistics partners can be an incredibly challenging and time-consuming process. Consultants take the burden off the client by streamlining these processes to ensure the efficient production of products.
How Contract Manufacturing Consultants & Comparator Drug Licensing Providers Work Together
While the functions of the two drug development supporting service providers vary, they provide complementary support throughout the drug development lifecycle.
a. Creating Efficiency in Clinical Trial Readiness
To do this, the comparator drug must fit perfectly with the investigational product’s schedule. Manufacturing consultants work with Clinical Research Organisations (CROs) to align the timelines of when both trial materials and comparator drugs will be ready.
b. Create Alignment in Regulatory Documentation
Both of these services work together by ensuring that the manufacturing protocols, batch documents, licensing certificates, and import/export permissions are aligned to reduce the potential for being audited.
c. Reduce Time-to-Market
The service providers manage the sourcing, licensing, manufacturing, and QC (quality control) processes to reduce the potential bottlenecks in the trial and/or regulatory submission processes.
d. Minimise Operational Risks
By working closely together, the short- and long-term consultants combine to reduce the operational risks associated with: - Disruption of the supply chain - Non-compliance with regulatory laws - Delays in production - Data integrity challenges - Operational inefficiencies
Key Benefits of Hiring a Contract Manufacturing Consultant
There are several reasons why the use of external consultants in conjunction with contract research organizations (CMOs) provides more value than the expense involved:
a. Rapid Vendor Selection
A consultant has established networks and extensive industry knowledge. Therefore, if you want to evaluate multiple CMOs, you can do so in just a few weeks instead of spending months doing so.
b. Prevention of Expensive Errors
Selecting the inappropriate CMO may lead to:
- Unsatisfactory batches
- Supply interruptions
- Regulatory fines
- Significant delays in the development of projects
This is why when you use a consultant to help identify a CMO, you will be able to make your selection based on Sound data.
c. Enhanced Negotiating Power
Since consultants deal with CMOs consistently, they know what typical market pricing looks like, how to structure a CMO contract, and how to negotiate with the CMOs.
d. Enhanced Quality Systems
Consultants help create a strong quality system that reduces risk during the inspection process.
Scalable Support
Consultants can modify their services to meet the requirements, budgets, and complexity of any customer, from a small startup biotechnology company to a large global pharmaceutical organization.
Why Comparator Drug & Pharma Licensing Services Are Essential for Global Trials
Clinical trials are increasingly being conducted in more than one country, with each jurisdiction having its own licensing regulations and laws of supply chain management and documentation policies. Trying to manage all this information and coordinate it internally can be a daunting task.
These services provide:
a. Speed Up Approval Time
The licensing partner has a good understanding of the regulatory pathway for that country and can provide you with the necessary approvals promptly.
b. Assurance of An Authentic Product
Source-to-site traceability assures compliance and safety for patients.
c. Optimisation of Costs
Using global price differentials can help you reduce your clinical trial budget considerably.
d. Efficient Import/Export Flow
The partner will facilitate the import/export process promptly, as they will coordinate the customs clearance and temperature-controlled transport throughout the entire process.
The Future of Outsourced Pharma Support Services
As Personalized Medicine, Biologic Drugs, and Advanced Therapies grow, it follows that there will be increasing demand for Specialized Manufacturing Expertise and Licensing Support.
Anticipated future trends in this area are as follows:
- Manufacturing Analytics Driven by Artificial Intelligence
- Digital Twin Technology for Process Modelling
- Sourcing of Global Comparators Supporting Regulatory Approval
- Blockchain Solutions Supporting Integrity Within the Supply Chain
- Tools for Automating Regulatory Documentation
Contact Manufacturers and Licensing Experts Will Rely More on Digital Ecosystems to Predict and Mitigate Risk and Optimize Decision-Making.
Conclusion
Pharmaceutical companies are no longer able to successfully navigate the manufacturing, regulatory and trial supply challenges of 2023 alone. As these processes have become more intricate and globalised, it is critical to establish strategic partnerships to allow for rapid market access, risk mitigation and maximised operational efficiencies.
With the assistance of a contract manufacturing consultant, your drug products will be created in accordance with the very highest standards of quality, compliance and operational efficiencies. Additionally, the services of a comparator drug and pharma licensing service provider to ensure that your clinical trials are supplied with all the regulatory-approved comparator drugs they require to continue uninterrupted throughout the clinical trial process.
The combined efforts of these two service providers will allow us to scale more intelligently, innovate more rapidly and bring to market life-saving medications more quickly and efficiently.