RegWeb Consulting Services
We help to accelerate the process of registration of therapeutics and thus, enhancing its access to patients. Our team has proficiency and thorough understanding for US, EU Canada, and Australia regulations and have many years’ of proven experience of interacting and negotiating with regulatory authorities for defining efficient regulatory strategy. By pooling our collective experiences and knowledge, the team represents a remarkable resource for pharmaceutical companies needing to supplement its in-house regulatory capability. We provide solutions to complex problems with agility and quality.
We also provide support in the emerging markets such as APAC, Middle East, African and Latam region.
Values
Our operating model is streamlined to our following core values:
Accountability
Of What We Do!
Communication
Being Vocal!
Quality Wins
Focus on Quality!
Eye-to-Detail
Detail-Driven!
Respectful
Always Respect!
Team
We are a team of problem-solving regulatory professionals with more than 41 years of cumulative experience in the pharmaceutical, medical and biotechnological industry. Our team has been working in numerous pharmaceutical industries and expert in regulatory intelligence.
Guriqbal Singh
Director, Regulatory Professional (M. Pharm/MBA)
Guriqbal Singh has been working in the pharmaceutical industry since 2006 with experience in international regulatory, CMC and regulatory intelligence.
He has an extensive experience in the project management of regulatory maintenance activities for global markets involving initial MAA, variations, renewals, and response to questions. He has conducted conformance reviews on regulatory dossiers and review of pre- and post-approval documentation for regulatory submissions.
He is a subject-matter expert (SME) for the registration requirements of emerging markets with special focus on ASEAN, APAC, GCC and Africa.
Kamil Basha Shaik
Regulatory Affairs Specialist (Master’s degree in Regulatory Affairs)
Kamil is proficient in eCTD CMC dossier authoring for Health Canada, EU, and global markets, he excels in compiling regulatory submissions with attention to detail. His expertise extends to post-approval dossier compilation, strategic implementation of CMC, and Establishment License strategies. With outstanding project management skills, effective communication abilities, and a commitment to teamwork, our specialist is well-equipped to navigate the complexities of regulatory affairs.
Alakananda Vadlamudi
Regulatory Consultant-Publishing (B. Pharm)
Alakananda Vadlamudi is a Regulatory Affairs Certified (RAC) professional with over a decade of experience in the Pharmaceutical industry. She is an expert in handling the filing of NDAs/ANDAs to the USDA and has extensive global labeling experience, including working with EU countries and US labeling submissions. Additionally, she possesses hands-on experience in medical device labeling and 510(k) submissions.
Mohammed Ahsan Siddiqui
Regulatory Affairs Specialist (M. Pharm)
Ahsan has 8 years of enormous experience of handling complex projects from pre-authorization to post-authorization stages.
He is well versed with process of product development from pre-clinical to market authorization stage. He is excellent in preparing high quality initial MAA, dossiers (eCTD formats) in regulatory submission through MRP, DCP or National routes across EU member states/UK as well as handling of Administrative, Quality and Safety variation procedures.
He has comprehensive exposure in problem solving activities in the pharmaceutical sciences having researched the global context of pharmaceuticals and associated with various seminars & presentations.
What our clients say
Our clients are the best testament to our acumen and capability.
“We have had the pleasure of working with our partners at RegWeb for several years across many clients and regions. The team are extremely detail orientated and organised when preparing their excellent written documents for regulatory submissions. Additionally, the team are very personable and integrate into projects seamlessly, they are our trusted partners in North America and we continue to build a Rapport year on year!”
Ifty Saiyed
“We from Clarivate Cortellis CMC intelligence team glad to provide this testimony to the work done by RegWeb team on providing the professional services to develop and further maintain the CMC Intelligence database. RegWeb consulting team have always done their best to meet the exact requirements of the CMC project and helped us to achieve the internal milestones to publish the content for Biologics development for identified Regulatory entities across the globe. And now we are pleased to extend their services for Small molecules maintenance as well.”
