Regulatory Staffing Services

Regulatory Staffing Services

Overview of Regulatory Staffing Services

To maintain the confidentiality of medicinal products and have complete visibility of regulatory activities on a daily basis, manufacturers prefer to have external regulatory affairs staffing support. However, the biggest challenge the industry faces today is finding qualified regulatory talent and Regulatory Staffing Services.

Templarpharma, a regulatory contract staffing partner, can help you overcome the resource gaps on time. We possess a track record of successful and on-time resource deployment to ensure that clients meet their organizational needs. Templarpharma offers on-time regulatory affairs staffing for pharmaceutical companies seeking expertise in regulatory compliance and submissions.

As a trusted partner, Templarpharma provides qualified and experienced regulatory professionals who understand the complexities of the industry and can navigate the constantly evolving regulatory landscape. With a deep understanding of regulatory requirements, Templarpharma’s team can support pharmaceutical companies in meeting their compliance obligations while ensuring timely market entry of their products.

By partnering with Templarpharma, pharmaceutical companies can focus on their core competencies while relying on Templarpharma to handle the regulatory affairs staffing requirements. Templarpharma’s commitment to delivering high-quality regulatory services ensures that clients receive reliable and efficient support throughout the regulatory process.

Templarpharma Expertise in Regulatory Staffing Services

Regulation expert of CMC:

  • The CMC regulation expert provides regulatory consultation services throughout the product development and manufacturing phases.
  • They help select a reference standard, offer guidance in designing specifications, protocols, and reports for development, process validation, exhibit batches, stability studies, and other aspects.
  • The expert also confirms the composition against the reference drug and interacts with various stakeholders in manufacturing and research quality on regulatory matters.
  • They support the interaction with Health Authorities and regulatory staffing services.
  • Provide regulatory submission strategies and roadmaps, and manage the team and regulatory submissions.
  • The expert serves as an interface between the management team and the regulatory affairs team and handles Health Authority queries with strategies and scientific justifications.

Regulatory CMC Expert:

  • The Regulatory CMC Expert prepares and executes regulatory submission strategies for various submissions.
  • Evaluates change controls, and provides post-approval submission strategies.
  • They also provide a checklist of documents required for all types of regulatory submissions and offer regulatory consultation during product development and manufacturing phases.
  • Including the selection of a reference standard, designing specifications, protocols. Reports for development, process validation, exhibit batches, and stability studies.
  • The expert conducts a gap analysis and regulatory assessment of generated source data to ensure regulatory adequacy.
  • They review the draft CTD sections for initial and post-approval submissions and provide guidance to other stakeholders on regulatory requirements.
  • Additionally, the expert manages the team, tracks upcoming submissions, ensures quality deliveries, and meets timelines with optimistic regulatory staffing services. They offer guidance to the team on regulatory updates and requirements and prepare a response submission strategy for Health Authority queries. Reviewing the draft response package.

Regulatory CMC Associate:

  • As a Regulatory CMC Associate, your responsibilities will include conducting a gap analysis of source documents and data to ensure adequacy.
  • You will also be responsible for authoring CMC modules for initial submissions such as INDs/IMPDs/NDAs/MAAs/BLAs/Dossiers/DMFs. And CMC packages for post-approval/LCM submissions like Supplements/Variations/Amendments/Annual Reports/Renewals.
  • Additionally, you will provide change control evaluations and post-approval submission strategies. Track lifecycle management submission timelines for Annual Reports/Renewals, and provide a documents checklist for all types of Regulatory submissions.
  • You will work closely with top Regulatory Staffing Services to implement Regulatory submission strategies and manage submission timelines and quality.
  • You will coordinate with multiple stakeholders to ensure that all necessary documents. And data are available and participate in knowledge-sharing sessions.
  • You will also be responsible for tracking upcoming submissions. Managing the submission timelines and preparing responses to Health Authority queries.