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About Us :

AblyReg Advisory brings integrity and accountability which helps our clients to obtain faster regulatory approvals. The firm provides regulatory solutions for a wide geographical landscape which includes the USA, Canada, EU, UK, Australia, SA, New Zealand, and ROW for finished formulations, active ingredients, nutraceuticals, medical devices, etc.

We believe in advising our clients at various stages of their projects by providing a clear line of vision that enables them to make a firm decision 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 18 years.

What We Offer :

A strong blend of advisory services and strategic solutions in the area of Regulatory Affairs, Pharmacovigilance, Clinical Research areas, GMP, and Business Alliance.

We also extend our support, 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 the 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 compliances 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 :

We believe in client-centric strategy and thus our mission is to share our knowledge and expertise with integrity, consistent quality, and thoughtfulness, keeping in view the challenging changes of the Pharmaceutical industry.

 

Our Key Factors :

  • Confidentiality is priority
  • Trust and Respect
  • Ownership

Our Aim :

Our aim is to ensure that our clients are able to sail through their journey from research and development to the market and beyond, by increasing productivity while maintaining a focus on their core competencies and by relying on us for prompt, well informed and unmatched reliable regulatory advice. Creating lasting relationships is key to how we operate.