AblyReg Advisory Information

The firm provides regulatory solutions for a wide geographical landscape which includes the USA, Canada, EU, UK, Australia, New Zealand, and ROW for finished formulations, active ingredients, and medical devices. We believe in advising our clients at various stages of their projects by providing clear line of vision which enables them to make firm decisions at an early stage. We are skillful in identifying the current regulatory requirement, gap analysis, facilitating its implementation, articulating regulatory strategies, undertaking filings in eCTD, life cycle management, due diligence of dossier, acquisition & divestment of MAs/ANDAs, etc. The integrity, accountability with consistent quality is the core value whilst the knowledge, insight and hands-on experience in various dimensions of regulatory assures silver line to the client's business growth. AblyReg Advisory is founded by Dr. Sarika Pardhe who brings in varied experience in the field of Regulatory Affairs, Clinical Research and Pharmacovigilance over the last 17 years. What We Offer :A strong blend of advisory services and strategy on Regulatory Affairs, Pharmacovigilance and Clinical Research.We extend our support to desired clients in finding potential partners for development, manufacturing, BA/BE CROs and Pharmacovigilance. We comprehend that timely and transparent regulatory solutions are vital for business growth which needs lucid and attentive combination of various technical aspects of pharmaceutical projects with business insights. We aim at providing careful attention to details to ensure that the regulatory compliance's are always fulfilled and at the same time gain commercial profitability. Finally, a stated key factor makes a foundation of good services. We believe in keeping promises, we do what we say. Our Mission :