What Is Pharma Consulting?
In biotechnology, pharmaceuticals, and medical devices, pharmaceutical consulting can help with product development. It is a gathering of experts who will provide guidance and training in nonclinical testing, clinical trial design, manufacturing, regulatory agency contacts, submission preparation and so on.
The Importance And Advantage Of Pharma Consulting
Pharma consulting is critical for ensuring growth by achieving objectives and maximizing investment. It may assist with market strategy, in which the customer adopts market trends to expand the firm internationally. It also explains how to save expenses by concentrating on investments and growth initiatives.
Standards Of Pharma Consulting
The pharmaceutical and cosmetic industries can benefit from the following consulting services:
Pharmaceutical Industry (API and Formulations)
- Assistance with document and data preparation
- Preparation of dossiers/submissions and evaluation and filing for different drug regulators across the globe
- Preparation of submissions to various international organizations in Europe, South America, Australia and Asia
- International regulations are taken into account
- Fulfilling international filing requirements
- Plans are revised when guidelines change
- Facilitate interactions with regulatory bodies, such as meetings and conference calls; discussions during the development stage; submissions; and the approval process
- Assist in responding to inquiries from regulatory agencies
GMP Auditing
- Preparation for USFDA, TGA, MHRA, MCC, ANVISA, EDQM and other
regulatory agencies - Gap analysis, document preparation, site-specific verification and counseling
- ICH Q7a Gap Analysis
- Verification of the appropriateness of quality risk management in accordance with ICH Q9
- Assist in establishing quality processes that comply with ICH Q10
Cosmetic and Excipient Industry
- EFFCI is an acronym that stands for “European Federation For Cosmetic Ingredients”
- Cosmetic cGMP compliance help according to ISO 22716:2007
- Assistance with EXCIPACT installation
- Gap assessments and verification services to help you deploy your system more effectively
- Supply chain management solutions for the pharmaceutical, cosmetics and excipient industries
Consulting
Rondaxe is a pharmaceutical consulting firm specializing in CMC consulting and delivering drug development and manufacturing strategies to the pharmaceutical business, emphasizing growing and specialty pharma firms. Rondaxe is led by a group of former pharmaceutical industry directors and senior executives with experience in chemical, fermentation, drug product, analytical development, supply chain strategy, manufacturing operations, quality control, quality assurance and regulatory affairs:
- Chemical Development
- Drug Product Development
- Manufacturing Cost of Goods Analysis
- Quality Assurance
- Process Research and Development
- Analytical
- Supply Chain and Manufacturing Strategy
- Fermentation and Biocatalysis Development
- Regulatory Affairs
For more information, visit Rondaxe online or call us today at (315) 469-2800.
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