Data Compensation and Arbitration Support
As part of the regulatory process, when a generic registrant acquires new products for their portfolio, they make a choice of generating supporting data on their own or relying on data generated by another company. In the latter case, the generic registrant is required by law to compensate the data holder.
Rath Consulting provides critical support in all aspects of this Data Compensation process starting with detailed and accurate data assessments to determine potential data compensation exposure. As the process advances, we continue the support with data compensation negotiations and if necessary final offer arbitrations.
Submission Preparation and Guidance
The key to a solid submission is to know the answers to potential questions from the regulators before they come. Rath Consulting has experience in multiple submissions across many current generic products and potential generic products in Canada. This ensures the client a higher degree of success in registration of their product.
After reviewing the needs of any new client and once we have a good understanding of what they can supply to the submission package as a whole, Rath Consulting Inc will build a complete proposal. It will detail the timelines for laboratory work required, and all documentation required before the work begins. We have access to one of the best labs in Canada and those required internationally to produce the GLP or non GLP reports required at cost effective rates. Once the decision is made to move forward, the client will be as actively involved in the submission development as they request.
Rath Consulting Inc, also uses the services of regulatory experts when necessary to add expertise to the submission approach. We have worked with Dr. Daniel Bechtel of PR Tox and Associates on numerous submissions to ensure a positive outcome for our clients. Dr. Bechtel worked with the PMRA prior to starting his own regulatory consulting business and understands the inner workings of the PMRA.
Regulatory Business Strategy
Most generic companies have the in-house expertise to tackle critical production and distribution aspects of the business but the regulatory side of the equation is often considered to be somewhat of a black box. Rath Consulting Inc addresses this shortcoming by working closely with companies and incorporating their business objectives into a comprehensive regulatory strategy that achieves established objectives in a cost effective manner. Supplementing the collaborative approach, success is accomplished by applying our extensive expertise in the following areas:
- Competitive Intelligence – providing an evaluation of the longevity of a product and associated risks
- Regulatory Assessments – Design of registration strategies to minimize data compensation exposure and ensure the shortest time to market
In addition to the purely regulatory aspects of product registration, Rath Consulting supports the legal aspects as well by assisting in the due diligence process. This helps to assure that potential pitfalls are avoided when acquiring new products for your portfolio.
Rath Consulting Inc spends time with government regulators to negotiate on behalf of the generic crop protection industry regarding issues facing registrants. In June 2010 the policy based guidelines became law and now with regulations in Gazette II, we can rely on them to move the data compensation process along. Rath Consulting Inc was at the table to offer a strong voice of generic companies in Canada.
Market Access Strategy and Liability Management
The development of any generic crop protection product and the registration of one, is only the first part of the equation to being successful. You need to be able to get to the market. Rath Consulting can show you how.
Rath Consulting purchases market survey information to support the decision process when selecting potential generic crop protection products in Canada. That along with distribution and retail share data, help our clients make sound product selection decisions for the market place.
Rath Consulting Inc maintains relationships with many of the current distribution, retail farm groups in Canada. With the passing of patent life and exclusive use of data, the emergence of generic crop protection solutions are now on the rise. Distribution, retail and farm groups alike are all interested to see how they can access some of these products. Rath Consulting has many key relationships across many players in the Canadian market that have been developed over the last 25 years in the Canadian market place. It can use this position to connect many generic companies to the shelf space required to sell their product.
Once product is sold in the market place, it creates revenue and liability. In order to be best manage liability associated with the application of crop protection products, one must be able to deal with it in a timely manner. Rath Consulting can provide complaint follow-up in field to record and analyze the issue at hand and provide closure based on the clients final direction. This can be done on a small scale or larger scale using some of the best trained aerologists already in the field.
International Product Registration
Rath Consulting Inc has developed many contacts globally that are now being used to help clients register products in countries outside of Canada. We have done registration work in North and South America, and Europe.
As part of our service we would be more than happy help you get registration activities started in these countries or to pass you onto experts located there if that is required.