GMP Registration & WHO COPP

I’m preparing a finished pharmaceutical product for global distribution and now need a regulatory affairs partner who can take me through two critical steps: securing Good Manufacturing Practice (GMP) certification for our facility and obtaining a Certificate of Pharmaceutical Product (COPP) that meets World Health Organization (WHO) requirements.

You will guide the entire process—mapping gaps against current GMP standards, organising and formatting the technical-quality dossier, and steering communication with the competent authorities until the final COPP is issued. Experience with Finished Pharmaceutical Products is essential; familiarity with CTD formatting or API dossiers is a welcome bonus for future phases but not mandatory for this engagement.

Key deliverables
• Detailed GMP readiness report with corrective-action plan
• Complete GMP application package and support through inspection/remote audit
• COPP dossier compiled to WHO guidelines, submitted and tracked to approval
• Final issued COPP and a brief hand-over memo outlining renewal/variation actions

I’ll provide existing SOPs, batch records, validation data, and any past audit findings. You bring the regulatory insight, up-to-date WHO format know-how, and clear communication so we can reach certification smoothly and on schedule.