Regulation and Reimbursment Scenario

The regulatory environment for pharmaceutical and bio-pharmaceutical companies is known for its challenging complexity as regulations and guidelines keep changing every year.

Companies are required to find better and efficient ways of tracking changes in rules and regulations. Regulatory approval is required, before launching a drug and this process becomes cumbersome since regulations differ across the globe.

Due to high cost of non-compliance, successful companies need a strong compliance foundation, (corporate objectives and policies included) and guidelines.

Key Questions:

•  Compare regional requirements across multiple countries?
•  How to make sure to meet regulatory requirements for submissions?
•  What all regulations are required to fulfill before entering into new market?
•  How the registry and regulatory process differ from one country to another?
•  What is the reimbursement scenario in particular country for any product?

MRA Group can equip client with the expert guidance, tools, and technology helpful to smooth your journey to approval. On the basis of our understanding we can say that regulatory compliance must not be viewed in isolation and should requires a holistic approach.

In comprehensive regulatory support, we help our clients to draft documentation in compliance with requirements, including regulatory opinions for public offerings, and investigator, and patient recruiting agreements.

How We Help?

•  Understand submission routes and local regulatory practices to ensure clients meet the requirements.
•  Track regulation changes, compare competitive products and prepare for meetings and inspections?
•  Access up-to-date and historical regulatory documents and approval information?
•  Support and prepare for regulatory inspections?

Our expert team has diverse experience when it comes to providing regulatory compliance counseling to clients in pharmaceutical and bio-pharmaceutical industry.

Our scientific, technical and compliance experts are capable of extending the help to resolve most challenging issues. We work with our clients to design and implement effective and efficient processes that assure continuous compliance. We help our clients stay current with the ever-changing regulatory environment.

Our experts can perform an internal audit to give an update on the compliance and finally to avoid the future non-compliance issues.

Make regulatory compliance more manageable, cost-efficient by taking advantage of our integrated portfolio of services.

Analysis Involved:

•  Pricing and Reimbursement (P&R) Analysis: Accessing the impact of changing regulatory environment in overall healthcare space. P&R examines alternative pricing and reimbursement mechanism to support and fulfill recommendations of our clients
•  Loss-of-Exclusivity (LOE) Strategies: We support our client in developing, broad-ranging strategic toolkit in order to cushion the patient loss impact as we evaluate and analyze all the probability a generic company will employ in order to penetrate into the market and gain market share.
• Regulatory System Analysis: We conduct deep dive analysis in order to understand and find the loop-holes in the existing regulatory system. This helps our clients to introduce their product into the market.

Business Impact:

•  Client can have through understanding of regulations and registry across different geographies.
•  To get reimbursement scenario for all the competitive products with different reimbursement schemes.

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