Regulatory Affairs

Welcome to RA Consultants

We are services company that encompasses innovative, cutting edge and high quality services. The company resource consists of high end professionals with proven track records in their domain of expertise.

Regulatory Affairs

As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and usage of medicinal products, being compliant with stringent requirements is becoming a challenging issue for product registrations and drug approvals. That triggers the need for well-defined Regulatory strategies right from the product development to life cycle management to addressing all submission requirements, and to comply with the mandatory requirements.

  • Strategic planning for a global clinical trial during development of a product
  • Strategic planning for entering various regions across the globe
  • Strategic planning to take the products approved in one region to other Regulated markets (for example, the USA to Europe or vice versa)
  • Stability study planning for all possible presentations / container closure system
  • Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route maps

Without sufficient understanding on right Regulatory strategy for specific cases, many companies face delays in product registration that affect the costs. Therefore, right partner for strategic planning and monitoring Regulatory changes is the key for successful commercialization of a drug product. With a proven track record to keep abreast with global market conditions and navigating clients across through their unique Regulatory requirements, RAC stands a preferred Regulatory strategic partner for any Healthcare company.

The services we offer are as below:

  • Submission & Management of Registration Dossier;
  • Post Approval Changes;
  • License Renewal;
  • Variations Dossier Preparation & Regulatory Responses;
  • Transfers;
  • Site Transfers, Variations;
  • Variations to the original variation.

End to End Dossier Life-Cycle Management

RA Consultants was established in the year 2013 and incorporated as a Single member (SMC) private limited company which is a solution providing services company. But the history of RA Consultants (SMC-Pvt) Ltd is far older than this; it all begins with the vision of our CEO, Mr. Nadeem H. Alamgir, who has served in both multinational and local Pharmaceutical Companies in sales, marketing and regulatory affairs, for 3 decades. Apart from this he was involved in different activities at national level for a better image of Pakistan. He has been instrumental in Pakistan’s membership in Asian Harmonization working party, which is an international organization working for harmonization of medical device regulation in Asian Countries and he is Pakistan’s industrial representative in the Group. Mr. Nadeem was also a member of Pharmaceutical reforms committee under former federal minister of industries and commerce Mr. Razzak Dawood from 2000 to 2002, and was a mover of Drug Act amendments in 2002 that were promulgated through Presidential Ordinance in the same year. He has been contributing to regulations for better quality of health care products in Pakistan. In his endeavor to seek better position of Pakistan in committee of nations he has also represented Pakistan in numerous Conferences and Events globally to project Pakistan as a peace-loving progressive country. After years of work he realized that that there is a lot to be done for Pakistan and he being an employee has limitation, considering this he established RA Consultants, as service providing company to assist businesses in different domains ranging from Regulatory Affair, Business development to Human Resource and Event Management. Today apart from providing services to many businesses, Our CEO Mr. Nadeem Alamgir is working with United States Pharmacopial Convention on a USAID project for capacity building of DRAP & Provincial Health Authorities for enhancing Quality of Medicines in Pakistan.

Since the formation of RA Consultants, we have served our Clients successfully and the number of our satisfied clients is growing day by day. At RA Consultants we believe in giving it all when doing business keeping in mind the law and regulations of the country. Our motto is PROFESSIONALISM HONESTY & DEDICATION towards our clients. We believe in telling the truth to our clients in our dealings. We never guide a client against the law, we do not believe in earning money but providing services. We are flexible in our terms while dealing with our clients we do not treat our clients as customers but believe them to be our partners in business.

End to End Product Life-Cycle Management

RA Consultants was established in the year 2013 and incorporated as a Single member (SMC) private limited company which is a solution providing services company. But the history of RA Consultants (SMC-Pvt) Ltd is far older than this; it all begins with the vision of our CEO, Mr. Nadeem H. Alamgir, who has served in both multinational and local Pharmaceutical Companies in sales, marketing and regulatory affairs, for 3 decades. Apart from this he was involved in different activities at national level for a better image of Pakistan. He has been instrumental in Pakistan’s membership in Asian Harmonization working party, which is an international organization working for harmonization of medical device regulation in Asian Countries and he is Pakistan’s industrial representative in the Group. Mr. Nadeem was also a member of Pharmaceutical reforms committee under former federal minister of industries and commerce Mr. Razzak Dawood from 2000 to 2002, and was a mover of Drug Act amendments in 2002 that were promulgated through Presidential Ordinance in the same year. He has been contributing to regulations for better quality of health care products in Pakistan. In his endeavor to seek better position of Pakistan in committee of nations he has also represented Pakistan in numerous Conferences and Events globally to project Pakistan as a peace-loving progressive country. After years of work he realized that that there is a lot to be done for Pakistan and he being an employee has limitation, considering this he established RA Consultants, as service providing company to assist businesses in different domains ranging from Regulatory Affair, Business development to Human Resource and Event Management. Today apart from providing services to many businesses, Our CEO Mr. Nadeem Alamgir is working with United States Pharmacopial Convention on a USAID project for capacity building of DRAP & Provincial Health Authorities for enhancing Quality of Medicines in Pakistan.

Since the formation of RA Consultants, we have served our Clients successfully and the number of our satisfied clients is growing day by day. At RA Consultants we believe in giving it all when doing business keeping in mind the law and regulations of the country. Our motto is PROFESSIONALISM HONESTY & DEDICATION towards our clients. We believe in telling the truth to our clients in our dealings. We never guide a client against the law, we do not believe in earning money but providing services. We are flexible in our terms while dealing with our clients we do not treat our clients as customers but believe them to be our partners in business.

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