Understanding Regulatory Requirements
Identify and know the applicable regulatory framework and regulations for product approval.
Regulatory compliance management is one of the critical steps in development and approval of drugs, medical devices and cosmetics. To overcome this challenge, effective regulatory strategy is used. At Medwisdom Lifescience, we provide highly beneficial and efficient regulatory strategy for your product compliance management and approvals.
Our strategic approach is designed to help companies overcome potential challenges while delivering output on time, so that your product reaches the market quickly while meeting all the required compliance and quality standards.
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The product development process for drugs, medical devices, and cosmetics are costly and time-consuming. A clear and efficient regulatory strategy helps simplify this process.
Identifying essential regulatory requirements at an early stage
Identifying potential risks before they become issues
Mitigation of identified risks through careful planning
Aligning your product with specific regulatory framework
Below are some pre-requisites for developing an effective regulatory strategy:
Identify and know the applicable regulatory framework and regulations for product approval.
Make sure you have in-depth knowledge of the product to meet your compliance goals effectively.
Build a team of experts familiar with both domestic and international regulations and compliance.
Execute the risk management plan for early identified potential risks in product development, clinical trial, or submission.
Allocate sufficient funds to meet regulatory demands and timeline.
Effective regulatory strategy serves as a reference guide for maintaining global standards and compliance. Unlock the success of your business with our expertise:
Define the right regulatory pathway for fast approval of products.
Making specific regulatory strategies as per region requirements globally, including FDA, EMA, and CDSCO.
Highly beneficial risk management plan according to identified potential risks.
Provides study design for conducting clinical trials, ensuring successful completion.
Assure compliance labelling design for packaging and labelling requirements.
Simplify the process of renewal, variations, and ongoing compliance efficiently.
Stay updated with global regulations and market trends for competitive edge.
Highly beneficial and optimized regulatory solutions with top-tier compliance.
Providing flawless eCTD submission for product approval for the US market.
Tackle new markets confidently without worrying about regulations.
Find answers to common questions about regulatory strategy and our services.
Contact UsRegulatory strategy for pharmaceutical products is a comprehensive plan that outlines the approach to navigate regulatory requirements, ensure compliance, and achieve product approval. It includes identifying regulatory pathways, managing risks, preparing documentation, and aligning product development with applicable regulations from authorities like FDA, EMA, and CDSCO.
Regulatory strategy is crucial because product development is costly and time-consuming. An effective strategy helps:
The key steps typically include:
Medical device regulatory strategy differs from pharmaceuticals in several ways:
FDA (Food and Drug Administration): US regulatory authority overseeing drugs, medical devices, and biologics. Requires IND, NDA, ANDA, or 510(k)/PMA submissions.
EMA (European Medicines Agency): European Union regulatory body coordinating drug evaluation and supervision. Uses centralized, decentralized, or mutual recognition procedures.
CDSCO (Central Drugs Standard Control Organization): Indian regulatory authority under the Ministry of Health. Governs pharmaceuticals, medical devices, and cosmetics under the Drugs and Cosmetics Act.
CE Mark: European conformity marking indicating a product meets EU safety, health, and environmental requirements. Required for medical devices sold in the European Economic Area. It's a self-declaration process (for lower risk devices) or involves notified body assessment (for higher risk devices).
FDA Approved: US Food and Drug Administration approval indicating a product has been reviewed and approved for sale in the United States. For medical devices, this typically means 510(k) clearance or PMA approval. For drugs, it means NDA or ANDA approval.
Both are regulatory approvals but for different markets with different requirements and processes.