Providing Strategic Regulatory Guidance/Advice to Pharmaceutical
and Biotech Companies Via Online

Call Toll Free: (855) 692-9108

Pharmaceutical Online Regulatory Advicing Portal

GRSAOnline Portal

For Start-up Biotech Companies - Get all of your regulatory development strategies and answers to regulatory questions/issues without the need of a comprehensive regulatory department or use GRSAOnline as an additional resource to supplement your existing regulatory department for projects in specialty therapeutic areas.

For Emerging small to medium size/big pharma - Get a second opinion or double check answers to regulatory questions/issues or a regulatory development strategy either developed internally  or provided by other consultants/CROs.

Get an overall guidance for a regulatory development of novel drugs in specialty therapeutic areas, or for established drugs for new indications/dosage forms seamlessly navigating across several hurdles.

Our principal areas of focus and strength:

Regulatory Strategies Critical to Phase I to Phase II/III or Phase II to Phase III Transitions
Depending on Whether the Drug is a First-in-Class NME or a 505(b)(2) Established Compound

End of Phase-1 or End of Phase-II (EOP 1/II) Strategic Result-Oriented Briefing Packages
• Include strategically crafted questions

Regulatory Input and Assessments of New Study Designs and Proposals
• Help to Align with Regulatory Mechanisms to Expedite Drug Development for Rapid Approval or attain a Significant Regulatory Milestone

Or use GRSAOnline for a second opinion or to double check your already set regulatory drug development strategy.

Click on 'How It Works'

Business Meeting, Pharmaceutical Regulatory Advice

Other Services

  • We review and provide constructive comments on regulatory reports and summary documents (i.e. clinical study reports, BA/BE reports, pharmacology, and toxicology reports etc).
  • Some of the reports and documents we look at not only from compliance perspective with regulatory guidelines but also from a strategic perspective to ensure acceptability to the regulatory authority therapeutic discipline reviewers.
  • You can also obtain feedback on or double check your preset strategies on drug development pathways with GRSAOnline.
  • Use GRSAOnline experts to enable content development of regulatory pertinent information and strategic points to consider which are required for key regulatory submissions/presentations to the FDA and other Agencies worldwide. 
    • Examples: End of Phase I/II briefing packages, Type A, B and C meeting letters and packages, Orphan Drug Designation, Fast-Track Designation, Advisory Committee Meetings (i.e. ODAC) EU Scientific Advice, PIP etc.

Contact GRSAOnline for sound advice on the development of your drugs.

NOTE - We will promptly inform you if GRSAOnline is unable to service your request/assignment.

LIABILITY OF GRSAOnline - In furnishing any Client/Company or individual with the Regulatory Advice Consulting Services, GRSAOnline shall not be liable to any Client/Company/Individuals or its creditors for errors of judgment or for any matters, except for willful malfeasance, or gross negligence in the performance of the Services.  It is further agreed and understood that GRSAOnline may rely upon information furnished to it by Client/Company/individual which GRSAOnline reasonably believes to be accurate and reliable and that GRSAOnline shall not be accountable for any loss suffered by Client/Company/individual by the reason of Client's/Company's/Individual's action or non-action on the basis of any advice, recommendation or approval of GRSAOnline, its employees, officers, directors or agents, except as provided above.