Waqar Akram

Regulatory Affairs Specialist | Pharma Compliance Expert | DRAP Regulations | Pharmaceutical Registration | WHO | ICH Guidelines | Medical Devices | Herbal & Over the Counter | Data Anlayis | Project Management.

About me

Proactive Regulatory Affairs professional with a proven track record in successful product registration and compliance management. Skilled in effective communication with regulatory authorities, adept at navigating diverse regulatory scenarios. Committed to ensuring seamless adherence to global standards and optimizing product approval processes.

Experties

Areas of expertise include:
1- Regulatory Submissions of Common Technical Document Writing/ Form 5F, Form 5D, Form 5A.
2- Product Renewals Form 5B
3- Herbal and Neutraceuticals: Expertise in HOTC Establishment Form-6, Enlistment Form-7, etc.
4- Medical Devices & Cosmetics: Proficient in Establishment License and Enlistment applications.
5- COPP/FSC issuance as per WHO Format.
6- Pricing Matters: Specialized in Hardship Case Application, Annual CPI Application, New Drug Entry
Application.
7- GMP Application and DML Application through PIRIMS/ Eapps.
8- ANF Groundcheck & Quota Allocation for Controlled Drug Substances and Pre-Cursor Chemicals.
9- Crafting Replies for Drug Inspectors, Drug Testing Labs, PQCB, DQCB, DRAP, etc..
10- Filing for Drug Sales License & Its Renewal
11- PSQCA Registrations of Consumer Products.

Education

  • Doctor of Pharmacy UVAS Lahore

  • FSC Pre-Medical BISE Lahore

  • Matric BISE Multan

PORTFOLIO SHOWCASE

Completed CTD Dossier/ Enlistment of H&OTC & Medical DevicesHimont Pharmaceuticals
1- Heparin Sodium (Under Review)
2- Choline Alfoscerate Soft Gelatin Capsules 400mg (Under Review)
3- Dr. Pain Capsule
4- Cache Tablet
5- Dr. Koff Balm
6- Oringa Jug PackPacific Pharmaceuticals
1- Diclofenac Sodium 75mg/3ml Ampoule
2- Moxifloxacin Infusion 400mg/250ml
3- Paracetamol Infusion 1g/100ml
4- Metronidazole Infusion
5- Lactated Ringer’s + Dextrose 5% 1000ml & 500ml Infusion
6- Lactated Ringer’s 1000ml & 500ml Infusion
7- Dextrose 5% + NaCl 0.9% 1000ml & 500ml Infusion
8- NaCl 0.9% 1000ml & 500ml Infusion
9- Dextrose 10% 1000ml Infusion
10- Dextrose 5% 1000ml & 500ml Infusion
11- Levopraid Injection (New Dosage Form Registration) 25mg/2mll
12- Half Saline 0.45% 1000ml & 500ml InfusionA.S Enterprises- Lahore
1- Blood Bags (Single, Double & Triple)
2- SD Biosensor Products (Covid-19 Ag, HCV, HIV/Syphilis, Malaria Pf/Pv, Malaria Pf/Pan, Dengue NS1Ag, Dengue DUO, Code Free Glucometer and Strips, SD Check Glucometer & Strips)
3- Monobind Elisa Range
4- Pushtikona Sachet (Imported nutraceutical Product)

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