Table of Content:
- What Exactly Is Pharma Consultancy?
- The Value And Benefits Of Pharma Consultancy
- Standards Of Pharma Consultancy
- Science. Experts. Fit-for-Purpose.
- Client. Partner. Strategic Relationships.
- Quality. Compliance. Regulatory.
Pharmacy Consultancy assists with product development in the sectors of biotechnology, pharmaceuticals, and medical devices. In addition, a group of experts advise and teach on nonclinical testing, clinical trial design, manufacturing, regulatory agency contacts, submission preparation, and other topics.
The Pharma Consultancy is critical for ensuring oncology growth by reaching objectives and making the most of investment. In addition, it may aid in market strategy, where the customer would follow market trends to expand the firm internationally. It also teaches how to cut expenses by focusing on investments and growth initiatives.
Can offer the following services to Pharma and Cosmetic industry.
Pharmaceutical Industry (API & Formulations)
- Assist with document and data preparation
- Preparation of dossiers/submissions and evaluation and submission to various drug regulators throughout the world.
- Preparation of submissions to various international organizations in Europe, South America, Australia, and Asia
- International regulatory regulations are taken into account.
- Meeting international filings
- Plans are being revised as guidelines change.
Facilitate engagement with regulatory authorities through meetings and conference calls, talks throughout the development stages, submissions, and the submission approval process:
Assist you in responding to regulatory agency inquiries
- Prepare your organization for the USFDA/TGA/MHRA/MCC/ANVISA/EDQM, among others. Gap analysis, document preparation, site-specific verification, and instruction are all part of GMP audits.
- ICH Q7a Gap Assessment
- Help you to develop quality processes according to ICH Q10.
- Quality Risk management adequacy verification as per ICH Q9
Rondaxe’s team includes chemistry, pharmaceutics, analytical development, route scouting and scale-up, GLP/GMP production, distribution, and drug product commercialization. Our team is knowledgeable and always up to date. The Rondaxe Team is a network of subject matter specialists ready to provide knowledge to your unique development and production difficulties. In addition, we have a broad list and understanding of pharmaceutical service providers to guarantee that the outsourcing partners you choose are fit-for-purpose—and at the correct price—for your stage of development.
The Rondaxe Way of rapid and informed decision-making is the sum of these elements. We reduce the “white space” between project milestones that forces you to wait for analysis or comprehension of ramifications, slowing your progress. These are the hidden expenses that we discover and reduce. Rondaxe has gone from early development to complete commercial success hundreds of times, not just once or twice. Ours is a broad and deep consulting firm linked to worldwide subject matter experts for the quickest response and most up-to-date expertise.
Since its founding, Rondaxe has lived by these association conditions to serve the industry with mutual respect. Our industry specialists and project managers work with you from process development to agency contacts and files, negotiations and contracts with service providers, commercial supply chain management, and final commercial success.
We understand the regulatory consequences of process and development choices, and we will accompany you to meetings and submissions with the FDA and other regulatory agencies. Allow us to assist you in conducting a thorough audit of your present or potential service providers (vendors), as well as overall manufacturing processes and strategies, to ensure quality and full compliance.
Rondaxe is one of the world’s largest and most experienced multinational CMC consulting firms. We work with both virtual pharma/biotech firms and multinational pharmaceutical customers from early development to commercial production. Comprehensive CMC solutions, medication development, manufacturing, and worldwide regulatory strategies are among the services provided. Rondaxe is an own pharmaceutical process software designed to help clients with data management, cost of goods, productivity analysis, and other features.
For many years, Rondaxe, like our namesake, has been a contributing part of our environment. As a result, we provide customers with both calm and depth as drugs proceed from discovery to IND, IND to NDA, and finally to successful commercial production and market launch.
Contact us to discuss how we can help you.