Our priority is the well-being and safety of all who rely on the pharmaceutical & biotech industry to continuously supply medicines to treat current and newly discovered diseases. By enhancing global standards of practice within pharmaceutical and biotech industries across all its disciplines, GxP Pharma offers the comprehensive capabilities and deep industry knowledge necessary to help solve the most complex issues.
Our consultancy services and training resources will inspire individuals and allied companies to achieve greater practices resulting in greater quality, safety and efficiencies to successfully progress from initial concept, innovation, research & development to commercialisation of existing and new medicinal remedies for all humans to benefit, in the shortest timelines.
As a pharmacist, Tushar has over 30 years of experience in the pharmaceutical industry. A passion for innovation and always looking to improve working practices and systems to enhance quality. GxP Pharma has evolved from a background of successful enterprises and projects to meet gaps in the industry for the provision of specialist consultancy services and training resources at all levels across all the GxP disciplines on one platform.
We can help with any of the following disciplines used in the pharmaceutical & biotech industry:
Good Clinical Practice (GCP)
Good Distribution Practice (GDP)
Good Documentation Practice (GDocP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)Good Pharmacovigilance Practice (GPvP)
Good Wholesale Practice (GWP)
With years of experience, our team can support all aspects of Pharmacovigilance commitments with existing or new marketing authorisations. Provide Qualified Persons for Pharmacovigilance (QPPV) services and local representation in global markets.
Having the correct regulatory platform from the earliest phase is one of the most critical tasks to ensure prompt approval of medicines and least ongoing maintenance attention. Our expertise and knowledge is well proven. We can advice and facilitate with:
- Regulatory strategise and plans.
- Representation to regulatory authorities for scientific advice prior to submissions.
- Compile eCTD dossiers,CMC, medical writing and/or perform due diligence and gap analysis.
- Formulation & development project management.
- Technology transfer.
- Product life cycle management.
A unique service to the industry to reach political and regulatory bodies for greater awareness of your products, influence existing policies and/or proposed bills that affect your position in the market. We can professionally represent, advocate and lobby on your behalf in confidence. Also facilitate and manage pre submission meetings with regulatory authorities for better understanding of regulatory pathway prior to submissions to avoid post submission hurdles and assure quickest time to get your products approved.
Every successful pharmaceutical company commands a robust and efficient Quality Management System (QMS), the backbone of GxP. As the company grows so does its complexities and responsibilities towards greater quality and regulatory compliance. Migration of the QMS to a digital platform is a vital step to future proof systems to enable growth with integrity across global territories. We can facilitate migration of existing QMS to a bespoke cloud based digital platform or create a new system to meet regulatory approvals of GMP, GPVP, GDP, GCP.
We can help with any of the following disciplines used in the pharmaceutical & biotech industry:
Good Clinical Practice (GCP)
Good Distribution Practice (GDP)
Good Documentation Practice (GDocP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)Good Pharmacovigilance Practice (GPvP)
Good Wholesale Practice (GWP)
Training materials can also be delivered in person and be tailored to meet your company's requirements.
We cannot claim to be an expert in everything. That's why we are always looking for outside help to author our guides and training materials to assure ongoing improvements to all pharmaceutical disciplines. Why not put your skills, knowledge and core expert subject area to good cause and help create our training materials for all others to learn and benefit from. Contact us to find more about how you can get involved.
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