Clinical Trial

Applying for Clinical Trials is a daunting yet necessary undertaking. With Approv's extensive experience with Health Canada, FDA, and EMA, we simplify the complexity and ensure accurate paperwork submission. We work with you to:

1. Negotiate and Submit Clinical Trial Applications (CTAs to Health Canada & INDs to the US):

   Our experts facilitate the application process, ensuring accurate submission and negotiation for Health Canada CTAs and US INDs.

2. Review Bioavailability/Bioequivalence Study Reports:

   We review study reports and data analysis, ensuring compliance with Therapeutic Products Directorate (TPD) requirements.

Product Evaluation

Product Review

1. In-depth Gap Analysis:

   Approv reviews your proposed product claims and formulation, offering advice and guidance on potential impacts on product classification.

2. Strategic Guidance:

   Our experts provide insights to optimize your product for regulatory approval, ensuring a smooth pathway to market.

Product Submission

1. Efficient Paperwork:

   Approv completes all required paperwork and submits your product application on your behalf.

2. Submission Review:

   We meticulously review the submission upon receiving the product classification to ensure accurate classification.

3. Collaborative Preparation:

   Working closely with you, we prepare the Regulatory Affairs (RA) license application, ensuring adherence to regulatory standards.

Product Launch Roadmap

1. Tailored Checklist:

   Based on your product's classification, Approv creates a step-by-step checklist for the successful distribution of your product in your selected country.

2. Strategic Guidance:

   Our roadmap outlines critical steps and highlights common pitfalls, providing strategic guidance for a successful product launch.

Market Authorization Holder

Navigating the complexities of market authorization is simplified with Approv serving as your dedicated Market Authorization Holder. Our services include:

1. Comprehensive Market Authorization:

   Entrust Approv as your MAH to navigate the intricate process of obtaining and maintaining market authorization. We ensure strict compliance with regulatory requirements, allowing you to focus on your core business operations.

2. Renewals and Updates:

   Our commitment extends to managing renewals and updates on your behalf. Stay confident that your market authorization stays current and aligned with evolving regulatory standards.

Label Review

Ensuring label accuracy is crucial in meeting consumer demand for transparency. Approv's specialists can help:

1. Meet Plain Language Labelling Requirements:

   We ensure your labels comply with Plain Language Labelling and readability standards.

2. Disclosure of Active Medicinal Ingredients:

   Our experts verify proper disclosure of active medicinal ingredients, aligning with Health Canada regulations.

3. Assessment of Label Compliance:

   We assess existing labels for compliance with current regulations, providing recommendations for updates.

4. Creation of New Labels:

   Working in line with your license, we create new labels to meet regulatory requirements.

Facility Registration & Listing (FEI)

Navigating FDA requirements involves technical validation and specific formats. Trust Approv to streamline these processes and keep your facilities compliant:

1. Proper Facility Registration:

   We guide you through the proper registration process, ensuring compliance with FDA regulations for selling regulated products.

2. Listing Requirements:

   Our experts handle the listing process, ensuring that your products are correctly listed with the FDA.

3. Renewals and Annual Submissions:

   We manage the timely renewal of food facility registrations and the annual registration and listing for medical device or drug facilities.

Medical Translation

As borders blur and markets expand, ensuring your regulatory documents are accessible in multiple languages is paramount. Approv's Multilingual Translation Services are designed to:

1. Bilingual Labeling Compliance:

   Guaranteeing compliance with bilingual labeling standards, especially essential for products in diverse markets.

2. Precision in Translation:

   Translating technical content with precision, maintaining the integrity of information across languages.

3. Cultural Nuances Consideration:

   Accounting for cultural nuances in translation, ensuring your documents resonate with diverse global audiences.

With Approv's Technical Writing and Translation Services, step confidently into a realm where precision meets clarity, and regulatory compliance knows no language barriers.

Discover the future of pharmaceutical and biotechnology submissions with Approv, where cutting-edge eCTD publishing meets seamless AI integration. Our meticulous services redefine the landscape, tailoring eCTD submissions to your product's unique needs.

Key Features

1. Data Requirements Definition:

   Precision in tailoring eCTD submissions to your product's specific needs.

2. Comprehensive Authoring:

   Expertise in crafting CTD Modules 1-5 reports and integral risk management plans for NDS and NDA submissions.

State-of-the-Art Platform:

1. Efficient Assembly:

   Facilitate eCTD assembly with ease.

2. Global Compliance:

   Ensure full compliance with global regulatory standards.

3. AI-Driven Expertise:

   Precision document formatting, strategic lifecycle planning, intelligent hyperlinking, and meticulous metadata handling for swift regulatory review.

Unparalleled Support:

1. Dedicated AI Experts:

   Guiding clients through every phase of the submission process.

2. Commitment to Quality:

   Unwavering commitment to quality, precision, and client satisfaction.

Intuitive AI Interface:

1. Robust Technical Support:

   Empowered by an intuitive AI-powered interface.

2. Continuous Updates:

   Stay ahead with the latest in AI technology, adapting to regulatory changes seamlessly.

At Approv, we understand the critical importance of timely and precise regulatory submissions. Let our innovation and expertise navigate the intricate task of regulatory submissions while you focus on your core objectives. Welcome to a seamlessly sophisticated and successful regulatory journey with Approv.

At Approv, we take pride in offering comprehensive GxP compliance services, ensuring that organizations in the pharmaceutical and biotechnology sectors adhere to the highest standards of quality and safety. Our services are strategically split into two main sections: Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), each meticulously addressing specific regulatory requirements and industry needs.

Good Manufacturing Practices (GMP) Compliance

Our GMP compliance services are tailored to ensure that clients meet all regulatory requirements for the manufacturing, processing, packaging, and holding of pharmaceutical products. We provide a range of services, including:

1. GMP Audits and Assessments:

   We conduct thorough audits of manufacturing facilities to assess compliance with GMP standards. Our audits identify potential areas of non-compliance and provide actionable recommendations for improvement.

2. FDA Mock Inspections:

   To prepare for FDA inspections, we offer mock inspection services. These simulations help identify gaps in GMP compliance and provide a roadmap for addressing these gaps before an actual regulatory inspection.

3. SOP Writing and Reviews:

   Our team assists in developing, writing, and reviewing Standard Operating Procedures (SOPs) to ensure they meet GMP requirements. We focus on creating clear, comprehensive, and implementable SOPs that form the backbone of quality manufacturing processes.

4. Quality System Implementation:

   We help implement robust quality systems that are essential for GMP compliance. This includes quality control, quality assurance, and risk management processes tailored to the specific needs of the client.

Good Clinical Practices (GCP) Compliance

Approv's GCP compliance services focus on ensuring the ethical and scientific quality of clinical trials.

1. GCP Audits and Site Inspections:

   Our experts conduct detailed audits of clinical trial processes, from study design to data reporting, ensuring adherence to GCP guidelines. Site inspections are carried out to verify that the rights, safety, and well-being of trial subjects are protected.

2. Training and Education:

   We provide comprehensive training programs for clinical research staff, focusing on GCP principles, regulatory requirements, and best practices in clinical trial management.

3. Regulatory Document Review:

   Our team assists in reviewing and preparing essential clinical trial documents, including protocols, informed consent forms, and investigator brochures, ensuring they comply with GCP standards.

Approv's GxP compliance services encompass a full range of activities necessary for maintaining the highest standards in pharmaceutical manufacturing and clinical research. Our expertise in GMP and GCP, combined with our commitment to quality and client satisfaction, positions us as a leading provider of compliance services in the industry.

Approv excels in streamlining global cosmetics registration services, placing a strong emphasis on Product Compliance and Regulatory Submission to guarantee that cosmetic products meet the most stringent global regulatory standards.

Product Compliance

1. Ingredient Review:

   Conducting thorough assessments of ingredients to ensure safety and compliance with regional regulations.

2. Labeling Compliance:

   Ensuring that labels adhere to legal requirements, including accurate ingredient listings and necessary warnings.

3. Lab Testing:

   Conducting comprehensive laboratory tests to identify allergens and restricted substances, ensuring compliance with established safety thresholds.

Regulatory Submission

1. Documentation Preparation:

   Creating essential documents such as product information files and safety reports to support regulatory submissions.

2. Regulatory Strategy:

   Developing tailored strategies for different markets, considering their unique regulatory landscapes.

3. Liaison with Authorities:

   Facilitating seamless communication and submissions with regulatory bodies to expedite the approval process.

4. Post-Registration Monitoring:

   Offering ongoing compliance monitoring and reporting after successful registration to ensure sustained adherence to regulatory standards.

Approv's commitment to excellence in cosmetics registration services, coupled with our meticulous approach to compliance and regulatory affairs, positions us as a trusted partner in navigating the complexities of global regulatory requirements for cosmetic products.