As cost and regulatory pressures increase, there is increasing demand to improve product supply chain efficiencies. This can be achieved by rationalising product ownership and movement, the latter including consideration of inventory, amount of warehousing and repackaging operations.
Real Regulatory can advise on the regulatory requirements for the regulatory aspects of supply chain rationalisation and review of drug supply chains for regulatory compliance, in the pharmaceutical, medical device, food supplement and cosmetic arenas. This includes application of central financial ownership models, and rationalisation of bill of fare materials against product movements. There are many challenges to overcome from both existing legislation and more recent legislation changes coming from the European Commission, for instance, the advent of the new Falsified Medicines Directive, amending directive 2001/83/EC. However, it is the national applications of site licencing and product movement requirements in this arena that add varied complexity in establishing a proposed framework for supply chain activities.
Supply Chain Consulting Services
- Establishing compliance.
- Determination of the relevant applicable legislation.
- Identification of the drivers dictating the priorities, e.g. product complexities, value or volumes.
- Assisting with the design of supply chain proposals.
- Review and validation of the supply chain proposals.
- Supporting the various project streams in decision making.
- Liaison with the relevant competent authorities to validate internal proposals.
- Obtaining independent local advice to validate internal proposals.
- Advising on contract and agreements framework.
- Assisting with defining roles and responsibilities in the new model.
- Advise on feasibility of back up or business continuity plans and repackaging requirements.
- Production of country specific briefs to specify any regulatory actions needed.
- Provision of expert input into positive product release proposals.
- Supporting the implementation of new models.
- Determine the requirements, support and co-ordinate regulatory submissions for timely implementation, according to the project plan.
Project: Redesign of European Supply Chain Operations
Client: Blue Chip Multinational
Challenges: The lack of consistent approach to the location of product warehousing in European countries.
Our Solution: The national legislative and practical requirements for each and every country were established to support the validation of the design of the supply chain framework. This included challenging the company’s internally held view, where necessary, by obtaining independent local advice.
Project: Review of arrangements in place for sale of a licensed medicine with regard to Good Distribution Practice (GDP) regulations
Client: Large multinational pharmaceutical company
Challenges : Complicated international drug supply route for drug substance, drug product and product ordering framework.
Our Solution: Real Regulatory drafted a report for the client, which detailed the current situation of the product supply chain and the responsibilities of the various entities involved in it. This report also gave recommendations as to how these entities could best comply with the general rules on GDP. A meeting with the client was held with the Real Regulatory team contributors to clarify the full subtleties of the process and to respond to any questions.
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