Regulatory
Our regulatory services can help devise tailored strategies, provide technical processes and on-going support in
Due-Diligence, Gap Analysis, New Product Authorizations...
DDReg Pharma has supported its customers with end-to-end regulatory and pharmacovigilance services for an extensive product portfolio. This includes generics, biologics, biosimilars, complex polypeptides, vaccines, medical device & combination products, biotech products and more. With an intel-base of over 120 global regulatory agencies for stringent and emerging markets, DDReg is the go-to-partner for all regulatory, drug safety, and compliance needs covering the entire product lifecycle.
For the first time, DDReg shall be exhibiting at the BIO International Convention in San Diego and would be delighted to meet fellow exhibitors, attendees, and decision-makers of the Pharma industry. Given the vast advancements within the biotechnology and cell & gene therapy (CGT) space, the need to partner with an expert is essential to ensure compliant product development and approval. Whether you require regulatory support for clinical trial applications or CMC advisory for CGT products DDReg has the global regulatory solutions you need.
Meet our Business Development team at the BIO International Convention in San Diego to discuss your requirements
for clinical regulatory, regulatory affairs, clinical safety, medical writing, and pharmacovigilance.
Director & Co-founder
Assistant Manager (Business Development)
Assistant Manager (Business Development)
Our regulatory services can help devise tailored strategies, provide technical processes and on-going support in
Due-Diligence, Gap Analysis, New Product Authorizations...
We optimize safety databases and technical ability to deliver high-quality and reliable safety measures with minimal risk across ICSR Processing & Submission...
Learn moreOur robust infrastructure and management processes ensure that dossier conversion. eCTD management and paper submissions are conducted efficiently and adhere...
Learn moreWe provide updated labeling and compliance packages, that assist in the development of Product Labeling, Artwork Review & Compliance and Claim Substantiation...
Learn moreThe highly experienced medico-writing team have developed procedures and templates to ensure the modules of CTD are detail-oriented and additionally...
Learn moreOur collaboration with patent attorneys, with more than 20 years of highly experience, enables effortless delivery of product launches, market authorizations...
Learn more