Regulatory Strategy At Early Stage
Identifying potential risks, developing effective regulatory strategy to mitigate risk, and ensuring strict adherence to regulatory compliance from the start of product development.
At Medwisdom Lifescience, we offer a broad range of regulatory services for product development across Industries including Pharmaceuticals, Medical Devices, and Cosmetics. Our expert team has more than 20+ years of experience in pharmaceuticals and medical devices.
Our experts know the simple and seamless pathway for meeting regulatory compliance and securing product registration for commercialization in Indian and International markets. We help you overcome complex regulatory challenges, ensuring fast product approval and marketing authorization.
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We understand the complete process of product development and what could be the potential challenges encountered during marketing authorization. We guide and support you from the initial step of product development to marketing authorization.
Early-stage planning and strong strategies to mitigate risk and challenges
Designing and optimizing assays as per Pharmacopeia standards using advanced statistical tools
Expert review of manufacturing sites ensuring they meet GMP regulatory requirements
Supporting clients in designing clinical trials to assess safety and efficacy per GCP
We guide and support you through every aspect of product development with our comprehensive regulatory expertise:
Identifying potential risks, developing effective regulatory strategy to mitigate risk, and ensuring strict adherence to regulatory compliance from the start of product development.
Development of assay for evaluation of API, statistical modeling for validation of data, and adherence to Pharmacopeia standards for global regulatory compliance of product.
Reviewing manufacturing sites to ensure they follow GMP, verifying the manufacturing process meets regulatory compliance, and designing validation protocols for maintaining product consistency.
Supporting clients in designing and planning clinical trials to assess safety and efficacy of products while maintaining Good Clinical Practice (GCP) standards throughout.
Assisting clients through preparing proper documentation necessary for regulatory submissions in accordance with global standards of CDSCO, FDA, EMA, and SFDA.
After product gains market access, we continue to assist clients through post-marketing surveillance, helping in maintaining regulatory compliance throughout the product lifecycle.
There are 5 stages of pharmaceutical product development. Every stage has unique challenges which requires expert advice and effective regulatory solutions. Medwisdom Lifescience is here to guide you through each stage:
The primary stage of product development. We ensure pharmaceutical products are developed in compliance with regulatory standards. Our expert advice helps clients identify the most promising approach, leading to successful regulatory submission.
Checking the safety and efficacy of the drug before it is tested on humans. We assure pharmaceutical formulation meets expectations of non-clinical studies, fulfilling all regulatory authority requirements of FDA, CDSCO, and EMA.
Providing expertise in designing clinical study reports from early phase to post-marketing surveillance. Covering Phase I, II, III, and IV protocols, meeting all GCP requirements, and streamlining the approval process for timely market access.
Assisting clients through preparing proper documentation for regulatory submissions. Our deep understanding of CDSCO, FDA, EMA, and SFDA helps achieve fast approval for products and timely market entry.
After the product gains market access, we continue to assist clients through post-marketing surveillance phase, helping in maintaining regulatory compliance throughout the entire product lifecycle.
Find answers to common questions about product development and our regulatory services.
Contact UsThe timeline for pharmaceutical product development varies depending on the product type, regulatory pathway, and market. Generally, drug development can take anywhere from 10 to 15 years from discovery to market approval. However, with an effective regulatory strategy and expert guidance from Medwisdom Lifescience, the process can be streamlined to achieve faster approvals without compromising quality or compliance.
If a product fails after market launch, several steps are taken:
Medwisdom Lifescience assists clients in managing post-market obligations and navigating the regulatory requirements in such situations.
Preparing for a successful pharmaceutical product launch involves several key steps:
The target audience for a pharmaceutical product refers to the specific patient population or healthcare professionals for whom the product is intended. Defining the target audience is critically important because it:
CDSCO (Central Drugs Standard Control Organization): Indian regulatory authority under the Ministry of Health governing pharmaceuticals, medical devices, and cosmetics.
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 across member states.
SFDA (Saudi Food and Drug Authority): Regulatory body governing product approvals for the Saudi Arabian market.
Medwisdom Lifescience brings over 20 years of regulatory expertise to every product development engagement. With our support, your product can achieve:
Our team provides strategic approach and practical solutions for maintaining product compliance, supporting growth of your business in Indian and international markets.