services
Audit
Audits: Level – MHRA, EU GMP, WHO,PICS, SAHPRA, USFDA)
Audit as per size of your company and systems- to identify the gaps in compliance with regulatory.
Recovering from non-compliance issues resulting from an audit
Audit of Suppliers- API & intermediate/Excipient/Packaging material
Quality audits and ‘mock inspection’s for key departments across the business to ensure an ongoing focus on compliance and continuous improvement
Completing detailed themed audits and data analysis to better understand client need, risk and opportunity areas for improvement, and client outcomes, in the context of the wider sector and external benchmark data.
Quality Audits:
Good Laboratory Practices (GLP) audit
GMP Audit of pharmaceutical plant
Vendor and Supplier GMP and GDP Audit
Global Compliance
Dossier Submission;
Our expert pharmaceutical consultancy team cover Regulatory Affairs, Pharmacovigilance and Quality Assurance across the globe.
We have our Regulatory Affairs experts with the country specific experience in different activities such as:
Regulatory strategy and FDA agency submission preparation.
Registering products with required MOH.
Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD & ACTD) and company specific registration dossier.
Documents review before the submission to eliminate queries/ rejection.
Drug Master File compilation for open and closed part.
Checking that leaflets and packaging material comply with the quality of the pharmaceutical company and the legislator;
Prepare summary of product characteristic, Pack Insert, Product rationale.
Assistance in Response to queries for submission to the Regulatory Agencies
Complete Assurance
Documentation; We provide guidance and support Writing Policies, Validation plans/SOPs and more. Review of your documentation in compliance with regulatory guidelines.
Completing quality audits and ‘mock inspection’s for key departments across the business to ensure an ongoing focus on compliance and continuous improvement
Completion of monthly analysis of incidents and complaints, highlighting trends and risks, and making recommendations for continuous improvement.
Contract Testing at optimal cost
Report Writing; to regulatory authority
Regulation
Compliance to issued non compliance from Regulatory;
Regulatory Inspections and Post-Audit Remediation Programs all to TGA, FDA and EMEA standards.
We are expert in GMP compliance, FDA Regulatory affairs and business support services.
Create solution that help you meet each compliance requirement
Projects
We guide /organize/monitor any new projects from scratch to production handover and Expansions.
Designing a new GMP facility
Effective implementation, review and updating of the Quality Management Plan.
Ensuring the project specific process, procedures and work instructions are documented, controlled and communicated effectively.
Get your products licensed and to market.
Pharmaceutical product development
Reviewing and monitoring adherence to the project specific process, procedures and work instructions.
Working closely with the Procurement Manager, Lead Document controller and Quality control team to ensure the process and procedures support the effective transfer of information from sub-contractors / suppliers.
Product launch consulting
Business Development
