Regulatory Service​ Germany

PHARMALANE UK also provides Regulatory Affairs Service in Germany and across the world. In addition, Pharmalane can also help you provide Regulatory Affairs experts in Germany, with numerous experiences, like document review, drug master file compilation, Preclinical and clinical overviews writing, and much more.

With one of the largest teams of seasoned Regulatory Affairs specialists, Pharmalane GMP auditing service in Germany is able to advise its clients through each phase of product development. They have assembled a professional team capable of delivering high-quality regulatory projects on schedule. Pharmalane is very adaptable and can outsource specific tasks or supply customers with comprehensive solutions. They have more than 25 years of expertise in this industry and have created a good reputation based on their integrity by delivering precisely what their customers require when they require it.

In addition to medical devices, medical gases, herbal medicinal goods, dietary supplements, and cosmetics, Pharmalane’s Regulatory Affairs professionals provide comprehensive solutions for all of their customers’ regulatory requirements pertaining to human and veterinary products. For both short-term and large projects, clients can take advantage of the company’s adaptable approach, which includes both outsourcing and in-house regulatory experts. The services of the top  GMP auditing service in Germany Pharmalane, consist of regulatory strategies, gap analysis, dossier preparation, eSubmissions, marketing material evaluation, translations, and life-cycle management.

Through their exclusive network of Regulatory Affairs specialists in Germany and the United Kingdom, Pharmalane can assist you confidently manage every regulatory difficulty. Pharmalane provides an array of early development services and support, including gap analysis, regulatory planning, scientific consultation, CMC, production of the IMPD, IB, and regulatory dossier compilation.

In addition to supporting and managing clinical trial application submissions, they handle enquiries from Competent Authorities. In addition, we provide regulatory help for CMC compliance and IMPD authoring. All types of competent regulatory support is available for those who need to effectively traverse clinical development with Pharmalane as their strategic partner.