Drug Regulatory & Compliance Consulting

In a constantly changing business environment, manufacturers of pharmaceuticals are in constant flux. 

Whether your goal is to market an oral medication, a sterile pharmaceutical, a novel dosage form, or just to modify an improved version of your existing drug, our regulatory affairs consultants can assist you and facilitate a smooth transition from concept to marketing across global locations.

We assist with the regulatory clearance for prescription medications, active pharmaceutical ingredients (APIs) and combination products (drug/device and drug biologic).  We also assist with regulatory concerns related to audit findings, assisting with corrective action plans, response letters and remediation actions.

We act as an extension of your regulatory team to facilitate a productive, positive relationship with regulators, and then sustain that positive relationship by providing the resources for your company to keep regulatory commitments. Our know-how provides the technical support you need to identify the tasks you need to meet regulatory compliance requirements, and then to help your staff execute those tasks and own the solution.

Our assistance includes, but is not limited to, the following range of services:

• Developing New Drug and Abbreviated New Drug applications (NDA and ANDA)
• Consulting on Pre-Investigational New Drug (IND) consultation
• Assisting with IND Applications
• Facilitating Drug Master Files
• Listing and registration for OTC Drugs
• Obtaining New Drug Codes (NDC)
• Performing Drug labeling review.
• Editing and writing technical information/package inserts
• Reviewing and Reporting Drug Pharmacovigilance and Adverse Events Data
• Supporting Pre-Approval Inspections

What do you need from our regulatory affairs consultants to help accelerate your product’s availability to the market?