What is Pharma Consultancy?
Pharmacy Consultancy provide assistance of product development in biotechnology, pharmaceutical and device fields. It is an affair of specialists that aims to advice and train nonclinical testing, clinical trial design, manufacturing, regulatory agency interactions, submission preparation and so on.
The Importance and Advantages of Pharma Consultancy
The Pharma Consultancy is important to ensure oncology growth by meeting the goals and making the most of the investment. It can help on market strategy where client will adopt the market trends to roll the company globally. It also helps on how to trim costs by focusing on investments and how to grow strategies.
Standards of Pharma Consultancy
The following services can be offered to Pharma and Cosmetic industry
Pharmaceutical Industry (API & Formulations)
- Document & Data preparation assistance
- Dossier/submission preparation or review and filing for various drug regulators worldwide.
- Submission preparation to other worldwide agencies in European Countries, South America, Australia, and Asia
- Consideration of international regulatory requirements
- Meeting international filings
- Revision of plans as guidelines change
Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process:
Help you respond to regulatory agency questions
- Preparation of your organization for USFDA /TGA/MHRA/MCC/ANVISA /EDQM etc . GMP audits by gap analysis, document preparation, site specific verification & guidance.
- ICH Q7a Gap Assessment
- Quality Risk management adequacy verification as per ICH Q9
- Help you establish quality systems in line with ICH Q10
Cosmetic & Excipient Industry
- EFFCI (European Federation for Cosmetic Ingredients)
- ISO 22716:2007 Cosmetic cGMP compliance assistance
- EXCIPACT implementation assistance
- Gap audits and verification services to assist you in better system implementation
- Pharma, cosmetic, and excipient industry supply chain management solutions
GQS Pharma Consultancy: Consultancy and Assistance as per 21 CFR Part 210, Part 211
GQS consultants can help you with the complete Pharma Consultancy process from documentation, implementation, trainings, internal audits and USFDA Approvals.
The process basically encompasses
1. Interacting with Consultants for Structures, HVAC to design as per USFDA requirements
2. Support in identification of relevant suppliers of equipments
3. Identification of Validation requirements and completing validation in line with USFDA requirements
4. Support in Product development and Commercialization in countries such as UAE, Singapore, Malaysia, UK, Romania, Qatar, Oman, Saudi Arabia, Yemen, Maldives, Indonesia.
5. Support in creation of Batch manufacturing record, Batch process records, Policies, Manuals, Standard operating procedures
6. Support in Electronic submission to USFDA.
7. Support towards meeting compliance requirements
8. Resolving issues related to contamination.
For training schedules, visit our Lead Auditor Training Page. We offer our service on the following countries/cities below:
India | Bangalore | Chennai | Goa | Mangalore | Pune | Mumbai | Delhi | Vapi | Indore | Hubli | Belgaum | Hyderabad
For more information, Visit us or Contact us.