Regulatory Support for Product Development

Do You Wants Regulatory Support For Product Development?

Bringing a product to market requires strong regulatory foundation to ensure compliance and smooth approvals. Accelerate your product development with confidence – partner with us today!

Product Development

At Medwisdom Lifescience, we offers broad range of regulatory services of product development for Industries including Pharmaceuticals, Medical Device, and Cosmetics. Our experts team have more than 20+ years of experience in pharmaceutical 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 products approval and marketing authorization. Let’s connect to get benefits of our unparalleled regulatory expertise and in depth Industrial knowledge.

Our Specialized Services In Pharmaceutical Product Development

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 initial step of product development to marketing authorization. Some of our expertise includes:

Regulatory Strategy At Early Stage of Product Development

product registration depends on early planning and strong strategies to mitigate risk and challenges by:

Identifying potential risk and challenges
Developing effective regulatory strategy to mitigate risk
Ensuring strict adherence to regulatory compliance

Design of Statistical Model

We design and optimize assay as per Pharmacopeia standards by using advanced statistical tools and modelling, these includes:

Development of Assay: For evaluation of API
Statistical Modeling: For validation of data
Pharmacopeia Standard: To ensure global regulatory compliance of product

Manufacturing Process and Facilities Review

Our industrial experts of more than 20+ years of experience, reviews the manufacturing site, ensuring they meet regulatory requirements. Here’s how it is executed:

Reviewing Manufacturing Site: Ensuring it follows Good Manufacturing Practice (GMP)
Regulatory Standards: Verifying the manufacturing process meets regulatory compliance
Validation Protocol: Designing validation protocol for maintaining product consistency and ensuring quality of product

Clinical Trials Planning

We support our clients in designing and planning of clinical trials to assess safety and efficacy of products. We assure the clinical trials are conducted while maintaining Good Clinical Practice (GCP).

Stages of Pharmaceutical Product Development

There are total 5 stage of pharmaceutical product development, every stage of development have unique challenges which requires experts advice and effective regulatory solutions. Medwisdom Lifescience is here to guide you through each stage:

Drug Discovery and Development

This is the primary stage of product development, we ensure pharmaceutical products are developed in compliance with regulatory standards. Our experts advice helps our clients to identify most promising approach, leading to successful regulatory submission.

Pre clinical Trials

The objective of pre clinical trial is to check the safety and efficacy of drug before it is tested on humans. We assure our clients pharmaceutical formulation meets expectations of Non- clinical Study, fulfilling all the regulatory authority requirements of FDA, CDSCO and EMA.

Clinical Trials

provides expertise in designing the clinical study report and make the process simple from early phase of clinical trial to post marketing surveillance. Our expertise includes:

Designing of clinical study protocol for conducting clinical trials smoothly (Phase I, II, III, & IV).
Meeting all the regulatory requirements including Good Clinical Practice (GCP).
Streamline the approval process of pharmaceuticals, for ensuring timely market access of products.

Product Approval

We assist our clients through preparing proper documentation necessary for regulatory submissions in accordance with the regulatory standards. Our deep understanding and extensive knowledge of global regulatory authorities like CDSCO, FDA, EMA, and SFDA helps to get fast approval for products.

Commercialization of Product

After the product gains market access, we continue to assist our clients through post marketing surveillance phase, helping our clients in maintaining regulatory compliance throughout product lifecycle.

Why Choose Medwisdom Lifescience For Product Development?

At Medwisdom Lifescience, we are confident in our expertise to address every challenges faced during product development, ensuring products are developed at high quality and safety standards. Our team provides strategic approach and practical solutions for maintaining product compliance, which may lead growth of your business. With our guidance and support your product can achieve:

Fast Regulatory Approval
Smooth Market Access
Commercialization

What Our Clients Think About Us

Biobee General Manager

As a General Manager, I highly recommend MedWisdom LifeScience Regulatory Services. Their expertise in navigating medical device regulations has been invaluable to our operations.

imperial Lifesciences Head Regulatory Affairs

Company services are excellent for CTD compliance and medical devices. Their expert team offers tailored solutions and efficient support. Highly recommended!

Genes2me Director

MedWisdom LifeScience Regulatory Services is a top choice for medical device companies. Their expert team offers tailored solutions to navigate complex regulations, ensuring compliance and efficient approvals. Professional and reliable, they are an invaluable partner in the regulatory process.

Frequently Asked Questions

How Long Does It Take To Develop a Product?

The time of product development depends on the nature of product and it’s complexity. It can range from few years for simple products to several years for complex molecule to develop as a product. Average time taken for the development of New Chemical Entity (NCE) is around 8-10 years.

What Happens If Product Fails After Market Launch?

If product fails post commercialization, the first step is to identify gap in the product and strategy, then survey and gather customer feedback, and consider redesigning of product.

How To Prepare For Pharmaceutical Product Launch?

The first step is to develop a strong and efficient strategy, marketing analysis, campaigning, supply chain management, sales training, and post product launch plans.

What Is Target Audience and Why It Is Important?

Target audience is a specific group of people that are most likely to use your product after its launch. They are important in designing the marketing strategy and gap analysis of product. Understanding the target audience can help to analyze demand of customers and making product cost effective with specific selection of product features.