CROlife’s regulatory outsourcing services offer companies the opportunity to outsource entire departments with the added benefit of an effective project management structure.

With the strain of resourcing taken away, the existing workforce can focus its efforts on other areas that promote company growth, such as product development and improving processes, while the interim function gets to work independently.

Our combined recruitment and regulatory expertise enable us to design an outsourcing plan that fulfils the company’s individual needs and is tailored to its business objectives, strategy and future vision.

CMC Services

CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.

Our CMC services include:

  • CMC content creation, compilation and maintenance support
  • CMC development biopharmaceuticals
  • CMC compliance

 

Global Procedure Management

The development and marketing of pharmaceuticals is a highly complex undertaking, not only involving several distinct disciplines, work streams and procedures but often also covering multiple countries or regions. The economic success of pharmaceutical companies heavily depends on their ability to take the right decisions regarding their marketing strategy and how they transform their vision into efficient operations.

Our global procedures include:

  • Pre IND an IND submissions
  • ANDA submissions
  • Centralized, Decentralized and Mutual Recognition Procedures

 

Health Authority interactions

Since Health Authorities make the final decision to approve or reject products, it is highly recommended to optimize authority communication and to hold face-to-face and teleconference meetings all along the development pathway. But how do you get the best out of your meeting with a Health Authority?

Authorities encourage to start discussions as early in the development process as possible so that developers can become aware of risks and weaknesses of their development plans to address them in a timely fashion. Meetings at critical milestones during development have been shown to dramatically increase the probability of timely approval.

CROlife has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle

 

Marketing and labelling activities

Product Labelling is a complex process that is highly affected by a constantly changing regulatory environment. A mistake in product labelling or bad readability can come at a high cost, which is why often times companies seek external support. In order to adhere to the legislation, product information related to manufacturing, safety and efficacy included in product labels, should be controlled by maintaining a central Company Core Data Sheet (CCDS).

We provide end-to-end support for the entire labelling process, which includes managing global and regional requirements, compliance, technology requirements, as well as proof-reading and translation services.

 

Our services include:

  • Development and maintenance of global regulatory product information
  • Preparation of supporting documentation – clinical and non-clinical overviews, expert statements
  • Alignment of CCDS with regional labels and vice versa
  • CCDS change descriptions
  • Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and label for marketing authorization applications
  • Literature searches
  • Communications with health authorities / agencies
  • Provision of labelling repository
  • Tracking and monitoring of current status and key milestones
  • Artwork management
  • Translation services
  • Proof-reading and readability testing

 

Regulatory Operation

Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing.

We regularly contribute to conferences and seminars to help guide thinking around subjects such as RIM/Regulatory Information Management, eCTD /electronic Common Technical Document submissions, and more.

CROlife provides inclusive regulatory operation services to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare, CMO and Clinical Research industry and we are dealing with regulated and semi regulated markets for submission in electronic format (eCTD, Nees format).

CROlife Regulatory operations qualified expertise team has sound experience as Regulatory Operations professional which includes submission management/planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), submission dispatch to regulatory authorities, archival and troubleshooting.

We have expertise in all kind of electronic submissions (eCTD and NeeS) like pre (original application, amendment to original application) and post approval (variations / supplement, annual report and PSUR)

 

Mergers & Acquisitions (M&A) Transfers and Due Diligence

CROlife  is able to leverage their extensive experience working on M&A related RA activities on both a European and worldwide level across multiple client programs to tackle these hurdles and allow current or prospective clients to achieve their corporate goals in a compliant and timely manner

CROlife analyses the regulatory status of medicinal and healthcare products as well as entire product portfolios on behalf of clients such as auditors, law firms and investors. We determine whether products are truly marketable in terms of regulation and whether their documentation and basis of data reflect the latest scientific findings.

In addition, we review the strategic potential of the products and markets that could be viable options with regard to new opportunities for claims, internationalisation and much more.

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