FDA Regulatory Consulting Firm Focused on Results Suzanne M. Sensabaugh is President and Principal Consultant of Hartmann Willner, where she is a (BLA ), controls supplements (CMC), and resubmissions related to these categories.

Vice President, Technical, Regulatory Consulting Services. Former regulator Previously worked with MHRA as a Pharmaceutical Assessor/ CMC Reviewer.

CMC RA consultants can “provide the knowledge, experience, guidance, and advice to help most effectively and efficiently achieve the highest probability of success in obtaining regulatory approval of a particular pharmaceutical product.” Who is CMC Regulatory Affairs a good career choice for, and how does one start a career in this area? Bryla CMC and CMC Regulatory Consulting. Independent CMC/Quality regulatory affairs consultancy, offering strategic advice and practical assistance with due diligence and dossier evaluation (gap analysis), regulatory project planning, dossier preparation, submission and follow-up for all types (MAA/NDA, IMPD/IND) of Global (European, US, Japan…) regulatory submissions. What are the different directions you can take in regulatory CMC? CMC for small molecules .

CMIC Groups’ CMC Consulting team supports our customers with evaluation of CMC data through Gap-Analysis for conducting clinical trials in Japan (CTN) and/or New Drug Application (J-NDA) filings in Japan. Key Responsibilities: Responsible for providing regulatory CMC support through the product life cycle (e.g., regulatory strategies, submission timeline development, change control and preparing submission documents). Create high quality, compliant CMC regulatory documents (eg, Core Dossiers, INDs, CTAs, MAAs, BLA, Variations and other relevant Regulatory Consulting CMC Cell & Gene Therapy Quality Global CMC Regulatory Consulting Services CMC (Chemistry Manufacturing and Controls) is at the core of most of MakroCare’s Regulatory activities. Over the years, CMC breadth and depth was developed to support several needs of clients, both small and large biopharma.

The work is independent but requires strong collaboration skills both with customers and in cross functional ProPharma Group teams such as CMC and Regulatory

Senior Consultant, Regulatory CMC (Small Molecules) Halloran Consulting Group 3.7 Boston, MA 02210 (South Boston area) Provide expertise in strategic interpretation of Health Authority regulations, guidance and directives to develop regulatory strategies and sound regulatory… New cmc regulatory consultant careers are added daily on SimplyHired.com. The low-stress way to find your next cmc regulatory consultant job opportunity is on SimplyHired.

Global CMC Regulatory Consulting Services. CMC (Chemistry Manufacturing and Controls) is at the core of most of MakroCare's Regulatory activities. Over the

They specialize in major areas of regulatory affairs, such as regulatory strategy, operations, CMC, and medical. BLA’s consultants are former developers themselves, designing, drafting, and implementing global The Consultant will be based in Summit, NJ and will assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives. Job Duties: Support Regulatory CMC Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global cell therapy applications. In 2010 Dr. Golec founded CMCRegAff, LLC with the primary focus to provide strategic, senior level, executive CMC Regulatory Sciences consulting services to the pharmaceutical and biopharmaceutical industries on small molecule Drug Substance and Drug Product dosage form for all CMC regulatory phases during the Investigational New Drug (IND, CTA) development and planning, submission and … CMC Consulting Services. Regulatory Affairs CMC. Write a description for this list item and include information that will interest site visitors. For example, you may want to describe a team member's experience, what makes a product special, or a unique service that you offer.

Across Tim Mitchell's career in the biopharmaceutical industry, he has helped bring over 20 drugs to market. He works with companies on Drug Product Commercialization, creating a Quality System for early and late clinical development, and commercial manufacturing, ensuring effectiveness of quality p CMC regulatory is pivotal in ensuring that drugs and treatments being manufactured are safe, effective and of a high quality for patients.
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cGMP compliance activities.

Our principal consultants all come from the pharma industry and the FDA with over 2 decades of experience on average. They specialize in major areas of regulatory affairs, such as regulatory strategy, operations, CMC, and medical. BLA’s consultants are former developers themselves, designing, drafting, and implementing global Consulting services providing Global Regulatory Affairs CMC strategy, support, and value throughout the drug development process, from discovery to clinical studies and through commercialization. Spark CMC Consulting Corp.
Sarepta therapeutics

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Responsibilities:Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other

What are the different directions you can take in regulatory CMC? CMC for small molecules . The most common career path for CMC consultants is to get a job in classical drug development, working with small molecules like paracetamol or ibuprofen. These are chemically manufactured active substance molecules that are used to make most drugs. As a CMC Regulatory Affairs consultant, you will be working in a multi disciplinary team and will be responsible for giving the team (incl. e.g. the CMC lead, process development rep, analytical rep) regulatory guidance and direction in order to finally arrive at a dossier that will meet regulatory expectations. The CMC regulatory consultant must be able to both We provide the expertise necessary to deliver quality CMC regulatory dossiers that expedite product approvals.