Our Services

Learn more about what Pharmconnect can do for your Regulatory CMC Process and Strategy:

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Regulatory CMC + Biologics Consulting

Happyway Pharmaconnect specializes in Regulatory CMC guidance and strategy for drug products for the US and global markets.

Document Strategy and Submittal

Document preparation is an integral part of the drug approval process and interactions with FDAs across the globe. Let us help with complicated regulatory environments.

Gene Therapy and Novel Drug Products

Gene-based products and other innovative products present unique challenges to the regulatory process.

We can help with your strategy for your new drug product line.

INDs and Clinical Trial Submissions

INDs and Clinical Trial approvals can take a lot of paperwork and FDA interaction, and can be a complicated process.

With over 20+ years of corporate Regulatory CMC experience, we provide quality advising for your company's IND submissions.

Regulatory Strategy and Planning

Whether your product is on a fast-track to market, or more on a long-term project with many lines of products, we can advise.

- Strategy Mapping for INDs
-Clinical Trial Document Advising
-FDA Submission Advising for US and Global Markets
-FDA Meeting and Question Preparation

FDA Questions and Response Strategy

We provide effective advising on the most strategic approach in responding to FDA questions and other requests for information or validation.

Let's connect, Pharmconnect.

Whether you're a recruiter or a corporate regulatory professional, get in touch with our team.

See what Pharmconnect can do for your Regulatory CMC

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