Services

We offer a wide range of services…

Services

We offer a wide range of services…

Strategy & Entity Management​

Supply Chain

QA & Compliance

Vendor Management

Product Launch

Strategy & Entity Management

The business model for Orphan Drug Consulting is unique and it requires a flexible, cost-efficient approach. Companies need to ensure that they are investing in the correct infrastructure while ensuring they do not get overburdened by entity, financial and legal set up costs across multiple countries for launch. You also need to ensure that your decision on entity location (or locations) works not just for financial reasons and tax optimization, but can also be implemented from a Supply, Regulatory and Compliance perspective.

Here at Orphan Drug Consulting, we understand that multiple considerations influence your entity and office location. Orphan Drug Consulting works closely with clients to provide strategic, structural and tactical insight to help your company make the best choice for its business model. Our experienced in-house team, in conjunction with our legal and taxation partners, have supported this work across a broad range of companies and come with the necessary tools to ensure that you understand the requirements from a Customs, VAT, Compliance, Financial and Legal perspective. We support you in mapping out flows of goods, ensuring appropriate alignment of physical, financial and virtual requirements and informing your team of the obligations each decision places on the company.

Once your strategy is determined, Orphan Drug Consulting can provide the support required to operationalize your decisions – fast. Our team is experienced in obtaining the necessary company, customs and compliance registrations to get your entity functioning and act as your interim team to represent you in wherever you choose to locate your business.

Orphan Drug Consulting also offers support in the physical set up of your office and facilities utilizing key vendors and providing interim resource to ensure this is completed using a tried and tested approach.

• Optimum Entity/IP Structure Mapping

• Entity Set Up

• Function Design & Implementation

• Functional Leader Mentoring

• Business Process Design

• Strategic Planning

• Regulatory Affairs & License Acquisition

 

• Financial Management

• Brexit/FMD

Legal & Taxation Advisors

• Recruitment Services

• Office Management

• Relocation Services

• Administration Services

Supply Chain

Robust and efficient Supply Chains are critical to your organization’s commercial success. It is not enough to simply manage planning and demand forecast activities: a successful and agile Supply Chain is built on cross functional alignment and an understanding of the pitfalls which can derail a shipment or order. An oversight relating to a customs valuation or an incorrect temperature shipment can affect your organization’s ability to launch on time and for small Orphan Drug companies, this can be critical to their market success.

Here at Orphan Drug Consulting, we are experts in managing complex supply pathways across the world and managing the unusual locations that Orphan Drugs can sometimes lead you to due to the genetic prevalence of an illness in a particular location. We understand that supply needs to be agile, flexible and cost effective, both from a manufacturing and distribution perspective. We ensure that your vendors are matched to your organization’s needs and ensure that launch timelines are managed efficiently.

Many organizations who are commercialising their first product also need support in developing key Supply Chain skills. We also understand that while supply is the responsibility of Supply Chain, there are many functions involved in executing successful supply distribution. We ensure that strategy and supply goals are aligned across Supply Chain, Quality Assurance, Regulatory Affairs, Commercial, Legal, Finance and Tax and we support companies in achieving this across the following areas:

• Configuring End-to-end Supply Network

• Customs & VAT Support

Implementation of Planning and Demand Forecasting

Introduction of Sales & Operations Planning (S&OP)

Selection and Implementation of Manufacturers and Distributors

Inventory Optimization and Modelling

Management of Artwork Including SKU Optimization

Creation and Development of Artwork and Associated Processes

Building an Effective and Scalable Customer and Logistics Service

QA & Compliance

Here at Orphan Drug Consulting, we understand that compliance not only spans the traditional Quality Assurance (QA) role but covers a wide range of activities. 

Our team bring the best of industry expertise to these activities with experience obtaining, implementing and maintaining multiple Manufacturing/Importers Authorizations (MIA’s) and Wholesale Distribution Authorizations (WDA’s). The team has acted as both Qualified Person (QP) and Responsible Person (RP) on these licenses and currently fulfill these roles for several clients along with having extensive experience in authoring Quality Management Systems and hosting successful regulatory agency inspections. We know that vendor oversight is a key part of an outsourced quality system and routinely support this work on behalf of clients, implementing and carrying out audit programs, quality and technical agreements and vendor approval programs. 

We also support Marketing Authorization (MA) activities, acting as a point of contact with the European Medicines Agency (EMA) on MA’s and ensuring your entity remains compliant with its MA obligations by implementing a cross-functional responsibility matrix. Our regulatory affairs expertise is enhanced by partnerships with consultants who can bring valuable experience to your team in all aspects of regulatory affairs. 

Other areas that the team support include QA oversight of technical transfers into contract manufacturers, set up of third party logistics (3PL’s) and providing input into launches by ensuring local requirements are understood and implemented as part of the launch plan. We understand the specific requirements that cold chain or controlled products require and can help you team to understand these extra considerations. Shipping qualification activities and artwork process implementation are two other key activities that our team provides expertise onto ensure that launches are executed in a smooth and timely manner. 

Finally, a gap we frequently find in our clients who are preparing to commercialise key products is the appropriate management of their trade compliance activities. We offer the necessary support to help you understand your obligations from a customs perspective and we ensure that your products are reviewed in advance of critical initial shipments, ensuring that delays at borders are minimised.

• QMS Creation & Management

• WDA/MIA License Acquisition

• Nominated QP on Client MIA Ensuring GMP Compliance and Subsequent Batch Release to Market

• Nominated RP on Client WDA Responsible for Distribution and GDP Compliance

• Designated Point of Contact on MA’s

Training for Local/Global Teams

Audits & Inspections Oversight

• Trade Compliance

Vendor Qualification & Oversight

• Shipping Validation

Quality & Technical Agreements

Vendor Management

Orphan Drug Consulting help a wide range of clients, ranging from established industry leaders to small and emerging pharmaceutical companies. As a result, we frequently see clients needing to outsource many of their activities and adopt a “virtual pharma” model, particularly at start-up stage when budgets are crucial, internal expertise can be limited and the organization awaits key data or approval timelines in order to make critical investments. Manufacturing, distribution, artwork, packaging, complaint management, offices/facilities, IT support, Responsible Person (RP), Qualified Person (QP), pharmacovigilance, regulatory support are key services which we at Orphan Drug Consulting typically see outsourced.

While your vendors perform work on your behalf, it is crucial to understand that the quality of their work directly impacts not just your business, but your reputation with the regulatory authorities as your organization is the product license owner. Conversely, in areas where the vendor is named on these licenses, they are sometimes seen to be the ones who are answerable to the competent authorities in the event of an issue, particularly when acting as a QP or RP on your behalf.

Understanding the particular skill set required to manage this environment is crucial to your organization’s success.

Orphan Drug Consulting brings years of expertise in managing relationships with your vendors. We have worked with multiple vendors globally across a range of different products and projects and can support you and your team in the smoothest and most effective selection and implementation vendor processes, ensuring you get the highest quality of service at an optimum cost.

Management of risk is also key when outsourcing these key activities and we offer support on the following services:

• 3PL/CMO RPF Process

Supplier Qualification Activities Including Due Diligence, Visits & Agreement Negotiation

3PL Implementation and Launch Mgt.

CMO Technical Transfer Oversight

• Trade Compliance

 

Training for Local/Global Teams

Audits & Inspections Oversight

Vendor Qualification & Oversight

• Shipping Validation

Quality & Technical Agreements

Product Launch

At what stage should you think about Product Launch in your company’s journey towards commercialization of products? Our experience is that it’s much earlier than you might anticipate! 

Here at Orphan Drug Consulting, our experienced team recognize the specific opportunities that arise for Orphan Drugs due to patients’ urgent need for these products. Launch is a continual process, beginning frequently with local country ‘Named Patient’, ‘Compassionate Use’ or ‘Managed Access’ programs and moving to commercial product once Marketing Authorisation approval is received.

Due to the differing and country specific requirements of each of the above programs, the knowledge and experience in executing these programs within the Orphan Drug Consulting team can support your company in the smooth and timely introduction of your product to patients most in need of it. Our understanding of what it takes from a Compliance, Supply Chain and Regulatory perspective within these local markets can support you in not only launching these programs quickly but will also help you embed the correct supply strategies to smoothly transition these countries into commercial supply. We complete this by ensuring the programs are managed utilizing approved vendors who can also support commercial launch activities and by putting processes in place that can be scaled and adapt as your company grows.

Supporting the launch of a product into a new market for a company can be challenging, especially when it comes to markets outside the US and EU. Here at Orphan Drug Consulting, we have launched products via multiple pathways in over 60 countries around the world. We understand the local requirements in each market and how to merge these requirements into your processes to ensure supply is available when reimbursement is agreed.

Local Market Supply Model Determination

• Optimum Route to Market Management

Early Access/Named Patient/Managed Access Program Management

Country-specific Launch Requirements e.g. ATU (France), Bollino (Italy)

• FMD/Serialization Management

Free of Charge/ Compassionate Use Product Supply

Cross Functional Launch Plan Management

Clinical Product Management

• Local License Acquisition

Country-specific Packaging & Artwork