AMS Regulatory Affairs

Introduction /About Us


AMS is a Health Care & Pharmaceutical consulting company where we value commitment and determination and we are passionate about taking you down the right path. Our entire business motto is to help our clients find the cream of the healthcare crop and we do this in various ways through our pharmaceutical business services, regulatory, business development, intellectual property matters,  Human resources & Recruitment and Regulatory Insight (Internet Magazine).

Established in 2015, Our highly qualified and experienced team from various backgrounds combines their experience, hard work, resilience and creativity to provide you the best possible service and cater to your problems with the perfect solution. We are passionate about giving you our best which is why your triumph is our devoir.

Our founders, having been involved in the pharmaceuticals industry for over 3 decades, found a gap in the market sector for handling pharmaceutical technicalities. So, in 2015, they decided to cater to that gap and started AMS with the aim to provide services in regulatory, technical, plant set up processes as well as recruitment, exclusively for pharmaceutical and healthcare sector.

We pride ourselves on being the first group in Pakistan to offer this entire range of services and we currently serve about 60 different companies in various stages of supplies.

We have an assiduous team of forward-thinking, competent and experienced individuals who come together from various backgrounds and complement each other in perfect harmony to give you the perfect solution.

Business Head Profile

AMS was founded by Dr. Ali Shahzad with the aim to provide Regulatory & business development services. He went in with the idea of a simple consultation firm which soon grew to include all the various services that they offer now.

Ali is a doctor of pharmacy with an MBA and a broad experience in the pharmaceutical industry. Previously he served a Swiss pharmaceutical giant as its Head of Business Development and Regulatory Affairs and he has garnered over 3 decades worth of experience in the pharmaceutical industry in the capacities of QA, production, marketing, business development and regulatory affairs.

Collectively, this experience means that Dr. Ali has a firm grip on the pharmaceutical industry and understands its dynamics which makes him more than qualified for consultation.

Ali is also technical consultant of various local & international Associations, he represent many technical forums & Drug regulatory authority of Pakistan (DRAP) and also registered consultant of Primary Insight (A US based Consultancy firm) for South East Asia.


AMS Regulatory Affairs

AMS regulatory affairs provides comprehensive facilitation to pharmaceuticals to overcome regulatory hurdles. Our experienced team provides simple regulatory strategies, performs thorough due diligence, assists in executing well-versed registration applications and provides hands on regulatory support. We continuously help our clients in order to achieve their targets in a particular time frame.

Offering our expertise in the following domains:

  • Providing complete regulatory affairs services to Pharmaceutical & Health Care Industry.
  • Registration of Biological and Pharmaceutical at DRAP
  • Enlistment of Alternative (Health&OTC), Medical Devices and Animal Health,
  • Acquiring licensing approvals for pharmaceutical plants.
  • Preparing registration files for DRAP and other authorities. Executing pricing applications, appeals and lobbying with officials.
  • Executing registration dossiers for export of products to foreign countries in accordance with the country’s specific requirements. We also prepare dossiers in common technical document format (CTD & eCTD), designed to be used across US, Europe and Japan.


  • Business Development
  • Registering pharma start-ups and facilitating its growth..
  • Assisting the process of product Manufacturing by finding licensed manufacturers for our clients’ products
  • Assisting the process of product marketing by finding marketer/ distributor for our clients’ products.
  • Product portfolio arrangement and its transfer / change of license holder

Sale & Purchase of Pharmaceutical Plants.

We have some successful ventures in our credit

  • Pharmaceutical Plant Sale & Purchase & its due diligence
  • Health care & Pharmaceutical running business sale & Purchase & due diligence

Pharmaceutical Raw Materials:


We arrange and Import Raw material (APIs & Excipients) of Pharmaceutical Products

Building up Pharmaceutical Plants:

AMS offers project management of pharmaceutical manufacturing & raw material producing plants. We have an experienced & dedicated team to buildup:

  • Architectural designing & Civil work
  • HVAC & Engineering
  • Fixing of Equipment & Plant
  • GMP Processes & Implementation
  • QA and its Validation
  • Production development
  • Processing of Regulatory approvals from DRAP